OLYMPUS
Received Jul 1, 2008
Report 8010047-2008-00116 · MDR key 1073708
Device
Generic name
Evis Duodenovideoscope
Manufacturer
Olympus Medical Systems CorporationModel number
TJF-140FLot number
NA
Product problems
- Replace
- Tears, rips, holes in device, device material
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING THREE THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHIES, THE FORCEPS ELEVATOR OF THE ENDOSCOPE TORE THE NON-OLYMPUS BALLOONS AND SPHINCTEROTOMES UTILIZED WITH THE ENDOSCOPE. THE PROCEDURES WERE REPORTEDLY COMPLETED WITH THE SAME ENDOSCOPE, BUT WITH OTHER NON-OLYMPUS BALLOONS AND SPHINCTEROTOMES. THE USER FACILITY REPORTED THERE WERE NO PATIENT INJURIES.
Additional Manufacturer Narrative
THE ENDOSCOPE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION NOTED THE PRESENCE OF TECH AT THE BASE OF THE FORCEPS ELEVATOR, WHICH MAY HAVE CAUSED THE USER'S EXPERIENCE. THE SOURCE OF THE DAMAGE COULD NOT BE DETERMINED. THE ENDOSCOPE WAS SENT TO THE ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER INVESTIGATION. IF SIGNIFICANT, ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS REPORT IS BEING FILED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.