SPYGLASS DIRECT VISUALIZATION SYSTEM
Received May 17, 2013 · Event occurred Apr 25, 2013
Report 3005099803-2013-03981 · MDR key 3118234
Device
Generic name
Mini Endoscope, Gastroenterology-urology
Manufacturer
Boston Scientific - MarlboroughModel number
M00546230Catalog number
4623
Lot number
ML00001185
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
68 YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE COMPLAINANT, THE DEVICE WAS DISPOSED OF AND IS NOT AVAILABLE FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS AND DELIVERY CATHETER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE A HOLE WAS NOTED IN THE SPYSCOPE'S INNER PACKAGING RENDERING IT UNSTERILE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPYSCOPE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBES AS FINE.