AESCULAP PL100RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653181094), received between Mar 18, 2021 and Jun 18, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL100R - CHOLANGIOGRAPHY CLAMP 5MM 330MM. THE INSTRUMENT WAS OCCLUDED (CANNOT FLUSH). THIS WAS IDENTIFIED IN STERILE PROCESSING OR DURING ROUTINE MAINTENANCE HOSPITAL STAFF WAS CONCERNED THAT THIS COULD LEAD TO PATIENT INFECTION SINCE THE DEVICE CANNOT BE PROPERLY BRUSHED THROUGH OR FLUSHED OUT. THERE WAS NO DESCRIBED PATIENT HARM. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028198 ↗
• InjuryMar 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL100R - CHOLANGIOGRAPHY CLAMP 5MM 330MM. ACCORDING TO THE COMPLAINANT, THE TIP OF THE DEVICE BROKE OFF. FORCEPS INVOLVED IN PATIENT INCIDENT WHERE TIP OF FORCEPS SNAPPED OFF DURING SURGERY. PROCEDURE WAS DELAYED AS PATIENT REQUIRED X-RAY TO LOCATE BROKEN TIP. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11517370 ↗