Megadyne 0021Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10614559100356), received between Nov 24, 2020 and Nov 24, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2020Material Puncture/Hole

  DURING RIGHT VATS PROCEDURE THE PATIENT WAS BURNED IN TWO PLACES, ABOUT THE SIZE OF A QUARTER AND A DIME, ON THE RIGHT LATERAL SIDE DUE TO A MALFUNCTION IN THE J-HOOK BOVIE TIP THAT WAS USED. UPON INSPECTION OF THE J-HOOK, A HOLE WAS NOTED IN THE MIDDLE OF THE SHAFT CAUSING THE BURNS. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Burn, Thermal

  MAUDE report 10903056 ↗

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