ABC 160656 (UDI 20653405003899)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20653405003899), received between Sep 21, 2017 and Sep 21, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2017Scratched Material; Scratched Material

  THE DISTRIBUTOR IN (B)(6) REPORTED A SCRATCH ON THE PACKAGING OF A 160656 LAP PROBE THAT WAS IDENTIFIED DURING INCOMING INSPECTION. IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED PRIOR TO DISTRIBUTION TO AN END-USER. THIS REJECTION REPORT WAS FOR (B)(6) 2017. CONMED RECEIVED IT AND THE DECISION TO NOT REPORT THIS COSMETIC DEFECT WAS MADE IN (B)(6) 2017. THE REPORTED DEVICE WAS RETURNED TO CONMED FOR EVALUATION AND A BREACH IN STERILITY WAS FOUND. THIS REPORT IS RAISED ON THE BASIS OF THE STERILE BREACH IDENTIFIED DURING THE DEVICE EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6884462 ↗