FDA Adverse Event Other Summary report: N

*

MDR report key: 664600 · Received December 14, 2005

Report

Report Number
664600
Event Type
Other
Date Received
December 14, 2005
Date of Event
November 23, 2005
Report Date
December 14, 2005
Manufacturer
OLYMPUS AMERICA, INC.
Product Code
KOG
Report Source
User Facility report
Reporter Location
IL, US

Narratives

Description of Event or Problem · 1

PATIENT WAS DIAGNOSED WITH OBSTRUCTIVE JAUNDICE. THE PATIENT WAS BROUGHT INTO SURGERY. ERCP, ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, SCOPE WAS INSERTED BY MD TO SMALL BOWEL. J43 CATHETER INSERTED FOR CANNULIZATION, JAGWIRE THREADED THROUGH UTS INSERTED TO MAKE SPHINCTEROTOMY THEN BALLOON PASSED TO REMOVE STONES. MD NOTICED A FOREIGN OBJECT CAME OUT OF THE SCOPE. MD PASSED SNARE AND REMOVED AN OBJECT FROM THE PATIENT. THE OBJECT APPEARED TO BE A PANCREATIC STENT. MD DIRECTED STAFF TO MAKE A REPORT ABOUT OBJECT FOUND. BALLOON PASSED AGAIN TO REMOVE STONES AND 10-7 STENT INSERTED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM. ADDITIONAL FOLLOW-UP REVEALS: IT IS OUR ASSUMPTION THAT THE STENT WAS FROM A PREVIOUS PATIENT. IT WAS DEMONSTRATED THAT THE DISPOSABLE CLEANING BRUSH DID NOT PUSH THE STENT OUT EACH TIME. THE SCOPE WAS SENT TO OLYMPUS FOR EVALUATION AND IT WAS RETURNED WITH THIS STATEMENT "FOUND NO OBVIOUS PROBLEM." OF COURSE, THERE WERE MANY OTHER COMMENTS RELATED TO THE PARTS THAT WERE REPAIRED BY ANOTHER COMPANY BECAUSE OLYMPUS WANTS HOSPITALS TO RETURN THE SCOPES TO OLYMPUS FOR REPAIRS AND MAINTENANCE. OLYMPUS COSTS ARE MUCH HIGHER. ONE COMMENT WAS THAT WE WERE NOT USING AN OLYMPUS CLEANING BRUSH. AGAIN, A STENT WAS PUT INTO THE SCOPE CHANNEL AND IT WAS DEMONSTRATED THAT THE DISPOSABLE OLYMPUS CLEANING BRUSH DID NOT ALWAYS PUSH THE STENT OUT. WE DETERMINED THAT THE PUSHER THAT PUTS THE STENT INTO THE PATIENT ALSO PUSHES A RETAINED STENT OUT. THEREFORE, WE DECIDED THAT WE WOULD ALWAYS PUT THE PUSHER THROUGH THE SCOPE AS PART OF THE CLEANING PROCESS. WE RECENTLY RECEIVED THE NEW ERCP SCOPE. IT ARRIVED WITH A NON-DISPOSABLE CLEANING BRUSH. THAT BRUSH DEMONSTRATED THAT IT WOULD PUSH THE STENT OUT. THEREFORE WE WILL USE THIS BRUSH FOR EVERY CLEANING AND THE BRUSH CAN BE STERILIZED AND USED MANY TIMES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * DUODENOSCOPE KOG OLYMPUS AMERICA, INC. TJF-160F *

Patients

Seq Age Sex Outcome Treatment
1 87 YR