AESCULAP PO346RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963520595), received between Mar 18, 2022 and Mar 18, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryMar 18, 2022Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A JAW INS. CLINCHING GRSP FEN.3.5MM 290MM (PART # PO346R) WAS USED DURING A ENDOSCOPIC HERNIA SURGERY PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE SURGERY, THE JAW OF THE LAPAROSCOPIC INSTRUMENT FELL OFF IN THE PATIENT. THE FRAGMENT WAS RETRIEVED. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: PO381R - HANDLE WITH RATCHET FOR 3.5MM INSTR. - LOT UNKOWN. PM986P - INSULATED OUTER TUBE 3.5/3.5MM 290MM - LOT UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13809125 ↗