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Adverse Event Report

COOK INCORPORATED RABINOV SIALOGRAPHY SET CHOLANGIOGRAM CATHETER   back to search results
Catalog Number SCS-T-32-S
Event Date 04/29/1996
Event Description

Cholangiocath was used for a cholangiogram during a laparoscopic cholecystectomy. The metal tip separated from the catheter while in the duct. The metal tip was retrieved without difficulty. Device has been returned except for metal tip.

 
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Brand NameRABINOV SIALOGRAPHY SET
Type of DeviceCHOLANGIOGRAM CATHETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
COOK INCORPORATED
1100 west morgan st
spencer IN 47460
Manufacturer (Section D)
COOK INCORPORATED
1100 west morgan st
spencer IN 47460
Device Event Key82630
MDR Report Key83291
Event Key78379
Report Number83291
Device Sequence Number1
Product CodeGBZ
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/10/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/1996
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date02/01/1999
Device Catalogue NumberSCS-T-32-S
Device LOT Number614210
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer05/10/1996
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

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