Megadyne 0020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10614559100318), received between Dec 10, 2018 and Jun 1, 2023 — classified as 4 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K913281); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Material Disintegration

  ON REMOVAL OF SUPPLY FROM BODY THROUGH TROCAR, SUPPLY ITEM WAS FOUND TO HAVE SHREDDED INSULATION AT CAUTERY TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037858 ↗
• MalfunctionSep 11, 2020Arcing of Electrodes; Human-Device Interface Problem; Arcing of Electrodes; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE MEGADYNE LAPAROSCOPIC L HOOK SPARKED AND CAUSED A SMALL BURN MARK ON PATIENT'S LIVER. THE CASE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10520710 ↗
• MalfunctionDec 10, 2018Peeled/Delaminated

  IT WAS REPORTED THAT PATIENT UNDERGOING LAPAROSCOPIC APPENDECTOMY WHEN NOTED A BLACK COLORED FOREIGN OBJECTS IN THE PERITONEAL CAVITY. THE MD CHECKED THE MEGADYNE HOOK SPATULA AND NOTICED SHEDDING IN IT THAT LOOKED LIKE PLASTIC SHAVINGS SEEN IN THE PERITONEAL CAVITY. THE SURGEON USED ANOTHER MEGADYNE HOOK SPATULA AND SAME THING HAPPENED. THE SHAVINGS AND MEGADYNE LAPAROSCOPIC J. HOOK ELECTRODES X2 WERE SENT TO PATHOLOGY FOR IDENTIFICATION AND GROSS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148038 ↗
• MalfunctionDec 10, 2018Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PATIENT UNDERGOING LAPAROSCOPIC APPENDECTOMY WHEN NOTED A BLACK COLORED FOREIGN OBJECTS IN THE PERITONEAL CAVITY. THE MD CHECKED THE MEGADYNE HOOK SPATULA AND NOTICED SHEDDING IN IT THAT LOOKED LIKE PLASTIC SHAVINGS SEEN IN THE PERITONEAL CAVITY. THE SURGEON USED ANOTHER MEGADYNE HOOK SPATULA AND SAME THING HAPPENED. THE SHAVINGS AND MEGADYNE LAPAROSCOPIC J. HOOK ELECTRODES X2 WERE SENT TO PATHOLOGY FOR IDENTIFICATION AND GROSS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8147989 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K913281. One submission often covers many models, so check the product and lot details in each record.

• Z-2097-2013 · Aug 7, 2013 · Terminated
  E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a ch