Megadyne 0100Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10614559100660), received between Mar 9, 2018 and May 14, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGERY IT WAS OBSERVED THAT THE TIP OF THE CAUTERY INSTRUMENT (GREEN-COATED ¿ PTFE) DISINTEGRATED, RELEASING PARTICLES INTO THE PATIENT¿S ABDOMINAL CAVITY. THE SURGEON PROCEEDED WITH THE REMOVAL OF THE PARTICLES BY SUCTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171784 ↗
• MalfunctionMay 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGERY IT WAS OBSERVED THAT THE TIP OF THE CAUTERY INSTRUMENT (GREEN-COATED ¿ PTFE) DISINTEGRATED, RELEASING PARTICLES INTO THE PATIENT¿S ABDOMINAL CAVITY. THE SURGEON PROCEEDED WITH THE REMOVAL OF THE PARTICLES BY SUCTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171535 ↗
• MalfunctionMay 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THE DURING A LAPAROSCOPIC SURGERY IT WAS OBSERVED THAT THE TIP OF THE CAUTERY INSTRUMENT (GREEN-COATED ¿ PTFE) DISINTEGRATED, RELEASING PARTICLES INTO THE PATIENT¿S ABDOMINAL CAVITY. THE SURGEON PROCEEDED WITH THE REMOVAL OF THE PARTICLES BY SUCTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171473 ↗
• MalfunctionAug 26, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE L HOOK WAS CAUGHT ON FIRE DURING PROCEDURE. THERE WERE NO PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893609 ↗
• MalfunctionSep 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAP CHOLE, A PIECE OF THE HOOK FROM THE DEVICE CAME OFF IN THE ABDOMEN, SURGEON WAS ABLE TO RETRIEVE IT. CASE WAS DELAYED BUT IT WAS ABLE TO BE COMPLETED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199280 ↗
• MalfunctionSep 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY THE COATING BELOW THE L ELECTRODE COMES OFF INTRAOPERATIVELY AND REMAINS IN THE PATIENT. NO REPORT OF PATIENT HARM.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134200 ↗
• MalfunctionFeb 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THAT A PIECE OF THE COATING ON THE SHAFT OF THE PRODUCT CAME OFF DURING THE PROCEDURE. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675802 ↗
• MalfunctionJan 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING LAP CHOLECYSTECTOMY, THE TIP OF THE MEGADYNE HOOK PEELED OFF A SECTION OF BLACK COVER WAS SEEN AND RETRIEVED. CASE COMPLETED WITH THE SECOND DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606433 ↗
• MalfunctionJan 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING LAP CHOLECYSTECTOMY, THE TIP OF THE MEGADYNE HOOK PEELED OFF A SECTION OF BLACK COVER WAS SEEN AND RETRIEVED. CASE COMPLETED WITH THE SECOND DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606429 ↗
• MalfunctionDec 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAP HYSTERECTOMY, WHEN USING THE MEGADYNE EZ CLEAN ELECTRODE CODE 0100 THE BLACK SHEATH CAME APART FROM THE ELECTRODE TIP. USED ANOTHER TIP TO COMPLETE CASE USED ANOTHER ELECTRODE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317991 ↗
• MalfunctionJun 28, 2021Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS 'BENT' AND THE OUTER LAYER IS SPLIT IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12078826 ↗
• MalfunctionMay 18, 2021Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS BENT AND THE OUTER LAYER IS SPLIT IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841371 ↗
• MalfunctionFeb 10, 2021Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE DEVICE MELTED VERY QUICKLY. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11306907 ↗
• MalfunctionDec 3, 2018Melted; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY, THEY WERE USING A 0100 L WIRE AND THE INSULATION IS DETACHED FROM THE WIRE PORTION. THEY ARE GETTING MELTING ON THEM. THE INSULATION IS MELTING OFF. THE BLACK INSULATION IS MELTING AT THE DISTAL TIP DURING THE ACTIVATION OF ENERGY TO REMOVE THE GALLBLADDER FROM THE LIVER BED. CASE COMPLETED WITH THE SAME DEVICE, THE ISSUE WAS NOTICED NEAR THE END OF THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125594 ↗
• MalfunctionMar 9, 2018Flaked

  PLASTIC PIECES FLAKED OFF TIP OF MEGADYNE LAPAROSCOPIC HOOK INSUFFLATION EQUIPMENT.

  Patient problems: No Information

  MAUDE report 7330438 ↗

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