SPYGLASS DIRECT VISUALIZATION PROBE
Received Oct 8, 2008 · Event occurred Sep 9, 2008
Report 3005099803-2008-05129 · MDR key 1196896
Device
Manufacturer
Boston Scientific CorporationModel number
M00546030Catalog number
4603
Lot number
0000812801
Product problems
- No Device Output
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008 THAT A SPYGLASS DIRECT VISUALIZATION PROBE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED THE SAME DAY. ACCORDING TO THE COMPLAINANT, WHILE TESTING THE PROBE DURING PREP, IT WAS DISCOVERED THAT "THE PROBE HAD NO PICTURE, NO VISUALIZATION." IT WAS FURTHER REPORTED THAT THIS WAS THE FIRST USE OF THE PROBE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER SPYGLASS DIRECT VISUALIZATION PROBE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."
Additional Manufacturer Narrative
ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVAL CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.