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Surgical device malfunction in pediatric surgery: manufacturer and user facility device experience (MAUDE) database
Ayaka Tsutsumi1, Richard S Herman2, Shin Miyata2
1Department of Pediatric Surgery, SSM Health Cardinal Glennon Children's Hospital, 1465 S Grand Blvd, St. Louis, MO, 63104, USA. ayaka.tsutsumi@health.slu.edu.
Insights
Surgical device malfunctions in pediatric patients are rare but can cause injury. Most issues involved surgical staplers failing to form staple lines or energy devices failing to seal, highlighting the need for continued vigilance and research.
Area of Science:
- Pediatric Surgery
- Surgical Device Safety
- Medical Device Malfunction
Background:
- Laparoscopic surgery is increasingly used in pediatric cases, increasing the importance of surgical device safety.
- Limited research exists on surgical device malfunctions specifically in pediatric procedures.
- This study addresses the gap by characterizing device malfunctions in pediatric patients.
Purpose of the Study:
- To identify and characterize malfunctions of surgical staplers and energy devices in pediatric patients.
- To analyze the types and frequencies of reported device malfunctions in this population.
- To assess the impact of these malfunctions on pediatric surgical outcomes.
Main Methods:
- Retrospective analysis of the Manufacturer and User Facility Device Experience (MAUDE) database.
- Inclusion of reports from 2017-2023 for patients aged 18 and under.
- Exclusion of duplicate entries, animal studies, adult patients, and reports lacking age information.
Main Results:
- 61 distinct cases of device malfunction were identified in pediatric patients (0.61% of total reports).
- Surgical stapler malfunctions (n=31) primarily involved the JustRight 5mm Stapler failing to form a complete staple line (83.9%).
- Energy device malfunctions included sealing failure (LigaSure, CoolSeal) and material fragmentation (Thunderbeat); 36.1% of incidents resulted in patient injury.
Conclusions:
- Despite safety protocols, surgical device malfunctions occur in pediatric patients.
- The voluntary reporting nature of the MAUDE database may lead to underestimation of malfunction incidence.
- Further research is needed to fully understand the scope and patient impact of these device malfunctions.
Background:
The increasing prevalence of laparoscopic surgery in pediatric cases underscores the critical importance of surgical device safety. However, research specifically examining device malfunctions in pediatric procedures remains limited. This retrospective database study aims to characterize the types of surgical stapler and energy device malfunctions encountered within the pediatric population.
Methods:
This study is a retrospective analysis of the Manufacturer and User Facility Device Experience (MAUDE) database to identify reported malfunctions of energy devices (Harmonic, Thunderbeat, LigaSure, and CoolSeal) and surgical staplers in pediatric patients. The review encompassed reports from 2017 to 2023, focusing exclusively on patients aged 18 and under. Duplicate entries were eliminated by comparing patient age, incident date, and incident descriptions. Reports involving animal studies, adult patients, or those lacking patient age information were excluded from the analysis.
Results:
From a pool of 12,040 incident reports, 75 (0.61%) pertained to pediatric patients. After eliminating redundancies, 61 distinct cases were examined, encompassing malfunctions of surgical staplers (n = 31), Thunderbeat (n = 8), LigaSure (n = 20), and CoolSeal (n = 2). No deaths were recorded. A significant proportion (83.9%) of surgical stapler malfunctions involved the JustRight 5 mm Stapler, with the primary issue being failure to form a complete staple line. In LigaSure and CoolSeal, the predominant problem was sealing failure. Thunderbeat most frequently exhibited material fragmentation. Overall, 36.1% of the incidents resulted in patient injury, including bleeding (with one transfusion), bowel perforations, and bowel obstructions. Two cases required conversion to open surgery, and five necessitated additional surgical interventions. No root cause of malfunction was identified.
Conclusion:
Although surgical devices undergo stringent safety protocols, malfunctions continue to be reported. The voluntary nature of the MAUDE database likely contributes to an underestimation of the true incidence of these events. Consequently, further research is warranted to comprehensively understand the nature and patient impact of device malfunctions.
