OLYMPUS CF-1TTS2
Received Mar 24, 1994 · Event occurred Mar 7, 1994
Report 2429304-1994-00026 · MDR key 14300
Device
Generic name
Flexible Sigmoidoscope
Manufacturer
Olympus Optical Co., Ltd.Model number
CF-1TS2Catalog number
23130
Lot number
NA
Product problems
- Component(s), broken
Patient
*
Narrative
Description of Event or Problem
ALTHOUGH THE SIGMOIDOSCOPY WAS SUCCESSFULLY COMPLETED IN THE OUTPATIENT TREATMENT FACILITY, IT WAS NOTED UPON WITHDRAWAL OF THE SCOPE THAT A PIECE OF THE BLACK HOOD WHICH SCRRREWS ONTO THE DISSTAL END OF THE SCOPE WAS MISSING. THE SURGEON REINSERTED THE SCOPE IN ORDER TO RETREIVE THE MISSING PIECE BUT HE WAS UNABLE TO RETREIVE IT. THE PT WAS TAKEN TO THE HOSPITAL WHERE THEY WERE ABLE TO RETREIVE MOST OF THE BROKEN HOOD. THE PT WAS DISCHARGED FROM THE HOSPITAL BECAUSE THE SURGEON WAS CONFIDENT THAT THE PT WOULD PASS THE REMAINING PIECE. THIS WAS LATER CONFIRMED BY THE PT AND SHE IS DOING FINE. OLYMPUS HAS ASKED THAT THE SCOOPE BE RETURNED FOR EVALUATION.