Megadyne 0020LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10614559102602), received between Apr 20, 2017 and Apr 20, 2017 — 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.

• InjuryApr 20, 2017Material Puncture/Hole; Material Puncture/Hole

  DURING A TRANSAXILLARY BREAST AUGMENTATION, THE INSULATION ON THE LAPAROSCOPIC ELECTRODE WAS COMPROMISED. THERE RESULTED TWO BURNS TO THE LEFT SHOULDER AREA AS A RESULT OF THE COMPROMISED INSULATION AND THE ALTERNATE CURRENT SITE WHICH RESULTED. THE PHYSICIAN CLASSIFIED THE BURNS AS 3RD DEGREE AND APPROXIMATELY 1CM X 3CM AND 2CM X.5CM. THE BURNED TISSUE WAS EXCISED AND PRIMARILY CLOSED.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 6508522 ↗

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