SPYGLASS DIRECT VISUALIZATION SYSTEM
Received Mar 28, 2012
Report 3005099803-2012-01141 · MDR key 2506920
Device
Generic name
Mini Endoscope, Gastroenterology-urology
Manufacturer
Boston Scientific - MarlboroughModel number
M00546230Catalog number
4623
Product problems
- Detachment Of Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS & DELIVERY CATHETER WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE A SMALL PIECE OF TUBULAR PLASTIC OR RUBBER WAS NOTED TO HAVE DETACHED INTO THE PATIENT. THE PHYSICIAN SUSPECTS THAT THE FRAGMENT MAY HAVE ORIGINATED FROM THE SPYSCOPE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) FOR THE REPORTED EVENT OF DEVICE DETACHMENT. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).