Megadyne 0100LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10614559102640), received between Feb 6, 2020 and Apr 23, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Explosion” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2020Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT DURING A LAPAROTOMY VAGINAL HYSTERECTOMY, THE TEFLON COATING AROUND THE ELECTRODE EXPLODED. A SECOND LIKE DEVICE WAS TRIED AND IT DID THE SAME THING. A FORCE TRIAD GENERATOR WAS BEING USED AT THAT TIME. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9993045 ↗
• MalfunctionFeb 6, 2020Explosion

  IT WAS REPORTED THAT DURING A LAPARATOMY VAGINAL HYSTERECTOMY, THE TEFLON COATING AROUND THE ELECTRODE EXPLODED. A SECOND LIKE DEVICE WAS TRIED AND IT DID THE SAME THING. A FORCE TRIAD GENERATOR WAS BEING USED AT THAT TIME. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9676659 ↗
• MalfunctionFeb 6, 2020Explosion

  IT WAS REPORTED THAT DURING A LAPARATOMY VAGINAL HYSTERECTOMY, THE TEFLON COATING AROUND THE ELECTRODE EXPLODED. A SECOND LIKE DEVICE WAS TRIED AND IT DID THE SAME THING. A FORCE TRIAD GENERATOR WAS BEING USED AT THAT TIME. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9676655 ↗

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