MODULINE 8393913Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207016251), received between Jun 26, 2020 and Jun 26, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Arcing” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2020Arcing; Arcing

  NOTE: THE CUSTOMER RETURNED A TOTAL OF 26 DEVICES AT THE SAME TIME FOR EVALUATION AND REQUESTED THAT THE DEVICES BE EVALUATED FOR CURRENT LEAKAGE AT ANY POINTS OTHER THAN WHERE CURRENT SHOULD BE DISCHARGING. THE CUSTOMER STATED THAT THE RETURNED INSTRUMENTS MAY OR MAY NOT HAVE BEEN INVOLVED IN A PATIENT INTRA-OPERATIVE INJURY. PATIENT HAD LAPAROSCOPIC CHOLECYSTECTOMY SURGERY ON (B)(6) 2019 AND RETURNED TO THEATER FOR REPAIR OF BOWEL PERFORATION ON (B)(6) 2019. AS THE CUSTOMER COLLECTED MULTIPLE DEVICES (COMPRISING FAR MORE THAN ONE SURGICAL SET) FOR TESTING, IT IS NOT POSSIBLE TO DETERMINE WHICH DEVICE(S) MAY HAVE BEEN POTENTIALLY INVOLVED IN THE REPORTED INCIDENT, AND WE WILL REPORT AGAINST ONE DEVICE TYPE 8393.913, BATCH NO. 1156606, WHERE ABNORMAL CURRENT LEAKAGE WAS DETECTED AND WHICH WE BELIEVE TO BE THE MOST LIKELY DEVICE TYPE TO HAVE CONTRIBUTED TO THE REPORTED ADVERSE EVENT. (NOTE: A TOTAL OF 3 PIECES 8393913 WITH DIFFERENT BATCH NUMBERS (1156606, M484390, AND 1014984) WERE SENT IN BY THE CUSTOMER, WHERE ABNORMAL CURRENT LEAKAGE WAS DETECTED. BATCH 1156606 WAS USED TO REPORT THE INCIDENT.) THE COMPLAINT REFERENCE IS (B)(4).

  Patient problems: Bowel Perforation; Injury

  MAUDE report 10201268 ↗