COOK 26 FR. CUTTING LOOP
Received May 23, 2011 · Event occurred May 1, 2011
Report 1835241-2011-00002 · MDR key 2107310
Device
Generic name
Resectoscopic Cutting Loop
Manufacturer
Cook UrologicalModel number
CL-2612-12-OLLot number
U1997365
Product problems
- Detachment Of Device Component
- Device Or Device Fragments Location Unknown
Patient
UNK
- No Information
Narrative
Description of Event or Problem
DURING THE PROCEDURE THE CUTTING LOOP CAME OFF (MAY HAVE BURNED OR CRACKED OFF). CUSTOMER IS CONCERNED THAT THIS MAY NOW STILL BE IN THE PT. TRANS CERVICAL RESECTION OF FIBROID. LOOP OFF DIATHERMY LOST WHILST IN SITU IN UTERUS. NOT ABLE TO ACCOUNT FOR MISSING LOOP - X-RAY AND ALL CHECKS/SEARCHES DONE.
Additional Manufacturer Narrative
EVAL SUMMARY: DHR REVIEW WAS PERFORMED ON (B)(4) 2011 WITH NO ABNORMALITIES FOUND. ON (B)(4) 2011, CRITICAL LENGTH, LOOP DIMENSIONS, DIELECTRIC STRENGTH AND CONTINUITY TEST CHECKED AND PERFORMED ON THE UNUSED SAMPLE THAT WAS RETURNED. SAMPLE WAS IN SPECIFICATION. USED SAMPLE WAS VISUALLY INSPECTED AND IT WAS NOTICED THAT THE LOOP WAS MISSING, THE DISTAL INSULATORS ARE BADLY BURNT. REMAINING PORTION OF LOOP WAS TAPERED TO A POINT. THE WIDTH OF THE LEGS OF THE DISTAL ASSEMBLY WAS SQUEEZED OR ALTERED FROM ORIGINAL MANUFACTURE SETTING.