Megadyne 0100LSRecalls & reported problems
Megadyne Medical Products, Inc. · E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, L-Wire Split Stem, 45 cm., Single-Use, for use with foot control pedal · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10614559102657), received between May 15, 2023 and May 15, 2023 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (12 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
Device problems
- Delivered as Unsterile Product12
Patient problems
- No Clinical Signs, Symptoms or Conditions12
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHEN THE CUSTOMER RECEIVED THE ORDER THERE WERE HOLES IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16936201 ↗MalfunctionMay 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHEN THE CUSTOMER RECEIVED THE ORDER THERE WERE HOLES IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16936042 ↗MalfunctionMay 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHEN THE CUSTOMER RECEIVED THE ORDER THERE WERE HOLES IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16934500 ↗MalfunctionMay 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHEN THE CUSTOMER RECEIVED THE ORDER THERE WERE HOLES IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931731 ↗MalfunctionMay 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHEN THE CUSTOMER RECEIVED THE ORDER THERE WERE HOLES IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931713 ↗MalfunctionMay 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHEN THE CUSTOMER RECEIVED THE ORDER THERE WERE HOLES IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931692 ↗MalfunctionMay 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHEN THE CUSTOMER RECEIVED THE ORDER THERE WERE HOLES IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931668 ↗MalfunctionMay 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHEN THE CUSTOMER RECEIVED THE ORDER THERE WERE HOLES IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931660 ↗MalfunctionMay 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHEN THE CUSTOMER RECEIVED THE ORDER THERE WERE HOLES IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931651 ↗MalfunctionMay 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHEN THE CUSTOMER RECEIVED THE ORDER THERE WERE HOLES IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931644 ↗MalfunctionMay 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHEN THE CUSTOMER RECEIVED THE ORDER THERE WERE HOLES IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931635 ↗MalfunctionMay 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHEN THE CUSTOMER RECEIVED THE ORDER THERE WERE HOLES IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931560 ↗
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 · TerminatedE-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
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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