SPYGLASS DIRECT VISUALIZATION SYSTEM
Received Jun 16, 2014 · Event occurred May 29, 2014
Report 3005099803-2014-02236 · MDR key 3874584
Device
Generic name
Mini Endoscope, Gastroenterology-urology
Manufacturer
Boston Scientific - MarlboroughModel number
M00546230Catalog number
4623
Lot number
ML00001804
Product problems
- Device Packaging Compromised
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS & DELIVERY CATHETER WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE PACKAGING WAS NOTICED TO BE PARTIALLY OPENED. ADDITIONALLY, IT WAS THE INTERNAL PACKAGING SEAL THAT WAS FOUND TO BE INTACT BUT LOOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.