NA 1806-0041Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540377975), received between Jun 7, 2022 and Jun 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Residue After Decontamination” (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.

• MalfunctionJun 7, 2022Residue After Decontamination; Residue After Decontamination

  AS REPORTED: "ON (B)(6) AT THE SANATRIX NURSING HOME, DUE TO A PRIVATE GAMMA 3 INTERVENTION, AN UNPLEASANT INCONVENIENCE OCCURRED; SHORTLY BEFORE STARTING THE OPERATION, WITH THE PATIENT ALREADY ANESTHETIZED ON THE OPERATING TABLE, THE INSTRUMENTALIST CHECKS THE GAMMA 3 INSTRUMENTS ON THE STERILE SERVING TABLE, AFTER INSERTING THE GUIDE WIRE INTO THE CURVED CANNULATED AWL CODE 18060041, ORGANIC MATERIAL COMPOSED OF CLOTS OF BLOOD AND BONE LEAKED ONTO THE STERILE SERVING TABLE IN FRONT OF THE OPERATORS. AT THIS POINT, STERILITY HAVING BEEN COMPROMISED, IT WAS DECIDED TO STERILIZE EVERYTHING AGAIN, TO CLEAN THE INSTRUMENT AND POSTPONE THE SURGERY FOR ABOUT 40 MINUTES (WITH THE PATIENT ALREADY UNDER DEEP ANESTHESIA)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14628792 ↗