MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. FLEXIBLE CHOLODOCHOSCOPE; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 03/28/2013

Event Type  malfunction  

Event Description

Patient had laparoscopic cholecystectomy with cholangiograms and laparoscopic common bile duct exploration with multiple large stone extractions.Flexible choledochoscope in operating room stopped working.On review the device was shown to be at the end of working life.No futher information is available.
=
manufacturer response for karl storz flexible choledochoscope, flexible cholodochoscope (per site reporter).
=
new scope purchased from karl storz under their exchange program.

• Brand Name: FLEXIBLE CHOLODOCHOSCOPE
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245 501
• MDR Report Key: 3893477
• MDR Text Key: 4539954
• Report Number: 3893477
• Device Sequence Number: 1
• Product Code: FBN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 115