LEUKOCLIP SD HANDLE
Received Aug 16, 2020 · Event occurred Jul 27, 2020
Report 8043484-2020-02520 · MDR key 10411866
Device
Generic name
Topical Approximation System
Manufacturer
Smith & Nephew Medical Ltd.Catalog number
66047111
Lot number
678943
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
H3, H6: THE DEVICE USED IN TREATMENT HAS BEEN RETURNED AND EVALUATED ESTABLISHING A RELATIONSHIP WITH THE REPORTED EVENT. THE VISUAL AND FUNCTIONAL FOUND NO FAULTS. PROBABLE CAUSES INCLUDE SET UP AND USE OF DEVICE. THE INSTRUCTION FOR USE MANUAL FOR LEUKOCLIP SD HAS BEEN REVIEWED, IT IS VERY IMPORTANT FOR THE PROPER FUNCTIONING OF THE DEVICE THAT THE HANDLE BEFORE SLIDING THE CARTRIDGE ON IS PROPERLY SET BY ALIGNING THE ARROWS. THE MANUFACTURING RECORDS SHOW NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATION AT THE TIME OF MANUFACTURE. THE COMPLAINT HISTORY FILE CONTAINS FURTHER INSTANCES. THIS INVESTIGATION IS NOW COMPLETE WITH NO FURTHER ACTION DEEMED NECESSARY. SMITH + NEPHEW WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL STAPLING OPERATION WITH LEUKOCLIP SD HANDLE AND A CARTRIDGE, THE STAPLES BECAME NOT TO CLOSED APPROPRIATELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.