CONMED 138113Recalls & reported problems
Conmed Corporation · CONMED Accessory Electrode, 3.5 Inch (8.89 cm) Flat Blade · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30653405003476), received between Jun 4, 2018 and Jun 4, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).
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 Product1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2018Delivered as Unsterile Product; Delivered as Unsterile Product
THE DISTRIBUTOR IN (B)(6) REPORTED A "TEAR" ON THE STERILE POUCH OF DEVICE. THIS WOULD BE AN OBVIOUS DEFECT TO THE USER AND WAS THEREFORE NOT DEEMED A REPORTED DEVICE FAILURE. HOWEVER, THE COMPLAINT DEVICE WAS RETURNED TO CONMED FOR EVALUATION AND A HOLE WAS FOUND IN THE PACKAGING THAT WAS LIKELY CAUSED BY THE DEVICE. NO PATIENT INVOLVEMENT AS THIS DEFECT WAS FOUND DURING INCOMING INSPECTION. THIS INCIDENT WILL BE REPORTED AS A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH REOCCURRENCE.
Patient problems: No Patient Involvement
MAUDE report 7566919 ↗
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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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