InjuryEZM
BAKES BILE DUCT DILATOR 3MM
Received Jul 2, 1999 · Event occurred May 26, 1999
Report 2916714-1999-00015 · MDR key 230065
Device
Product problems
- Detachment Of Device Component
- Device, or device fragments remain in patient
- Tip breakage
Patient
54 YR
- Surgery, prolonged
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
EXACT SURGICAL PROCEDURE UNKNOWN, HOWEVER, AN AESCULAP DILATOR WAS BEING USED WHEN THE DISTAL TIP FRACTURED AND LODGED IN BILIARY DUCT. RETRIEVAL OF FRACTURED TIP WAS UNSUCCESSFUL AND EVENT PROLONGED SURGERY TIME. PT IS BEING MONITORED BY SURGEON ON OUTPATIENT BASIS AND NO COMPLICATIONS HAVE BEEN REPORTED. THIS EVENT TYPE IS OCCURRING BELOW THE FREQUENCY AND SEVERITY THAT ARE USUAL FOR THIS DEVICE.