Megadyne 0100SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10614559100677), received between Jun 21, 2018 and Dec 15, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A PIECE OF THE INSULATED TIP BROKE OFF (THE INSULATION PART NOT THE TIP). NOTICED DURING PROCEDURE BUT PRIOR TO USE IN PATIENT. NO PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804709 ↗
• MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THAT A CAUTERY WANDS HAD PIECES OF THE INSULATION BROKEN OFF INSIDE OF THE PATIENT DURING LAPAROSCOPIC SURGERY. IT IS THE PIECE THAT COVERS THE TIP, INSULATED PIECE. THE PIECES WERE RECOVERED AND NO ADVERSE EVENT. NO CONTACT WITH ANOTHER METAL DEVICE/INSTRUMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393766 ↗
• MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT IN A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THAT A CAUTERY WAND THAT HAD PIECES OF THE INSULATION BROKEN OFF INSIDE OF THE PATIENT DURING LAPAROSCOPIC SURGERY. IT IS THE PIECE THAT COVERS THE TIP, INSULATED PIECE. THE PIECES WERE RECOVERED AND NO ADVERSE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233919 ↗
• MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT IN A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THAT A CAUTERY WAND THAT HAD PIECES OF THE INSULATION BROKEN OFF INSIDE OF THE PATIENT DURING LAPAROSCOPIC SURGERY. IT IS THE PIECE THAT COVERS THE TIP, INSULATED PIECE. THE PIECES WERE RECOVERED AND NO ADVERSE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233717 ↗
• MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAP CHOLE, THE BACK FROM THE TIP OF THE DEVICE'S COATING APPEARED SHEARED AWAY. THE SURGEON THEN OPENED A MEDTRONIC HOOK TO COMPLETE THE PROCEDURE. THE SURGEON CONCERNED TO GET ALL REMNANTS OUT OF PATIENT. THE SURGERY WAS DELAYED 7 MINUTES AND THE CASE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. THERE WERE FRAGMENTS GENERATED BUT THEY WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445361 ↗
• MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAP CHOLE, THE BACK FROM THE TIP OF THE DEVICE'S COATING APPEARED SHEARED AWAY. THE SURGEON THEN OPENED A MEDTRONIC HOOK TO COMPLETE THE PROCEDURE. THE SURGEON CONCERNED TO GET ALL REMNANTS OUT OF PATIENT. THE SURGERY WAS DELAYED 7 MINUTES AND THE CASE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. THERE WERE FRAGMENTS GENERATED BUT THEY WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445339 ↗
• MalfunctionFeb 3, 2020Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE INSULATION BECAME DETACHED FROM THE TIP. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9661977 ↗
• MalfunctionJun 28, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ¿LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE MEGADYNE L HOOK, SMALL BLACK PIECE OF INSULATING PLASTIC ON BACK OF L HOOK CAME OFF. THE PIECE WAS RETRIEVED AND REMOVED FROM THE PATIENT¿S ABDOMEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8745469 ↗
• MalfunctionSep 7, 2018Arcing; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A GYN PROCEDURE, A LARGE FLASH OR ARCING WAS NOTED DURING ACTIVATION WITHIN THE ABDOMINAL CAVITY. UPON INSPECTION, A TEAR OR WEAKNESS IN THE INSULATION WAS NOTED AND THE DEVICE WAS REPLACED. THERE WAS A 3-5 MIN DELAY, NO PATIENT COMPLICATIONS KNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7856650 ↗
• MalfunctionAug 13, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE INSULATION DETACHED FROM THE DISTAL END OF THE TIP AROUND THE WIRE ELECTRODE. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7777067 ↗
• MalfunctionJun 21, 2018Break; Arcing

  IT WAS REPORTED THAT DURING A GYN PROCEDURE, A LARGE FLASH OR ARCING WAS NOTED DURING ACTIVATION WITHIN THE ABDOMINAL CAVITY. UPON INSPECTION, TEAR OR WEAKNESS IN THE INSULATION WAS NOTED AND THE DEVICE WAS REPLACED. THERE WAS A 3-5 MIN DELAY, NO PATIENT COMPLICATIONS KNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7627571 ↗

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