MalfunctionHCF
WECK EFX SUTURE PASSER ONLY
Received Apr 3, 2026 · Event occurred Mar 9, 2026
Report 3011137372-2026-00088 · MDR key 24782525
Device
Generic name
Instrument, Ligature Passing A
Manufacturer
Teleflex MedicalCatalog number
EFXSP1
Lot number
ML-000940
Product problems
- Material Integrity Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT "AT THE END OF THE SURGICAL PROCEDURE WHEN THE FASCIAL CLOSURE DEVICE WAS USED IT WAS NOTED THAT THERE WAS A PIECE MISSING FROM THE DEVICE AFTER IT WAS REMOVED FROM THE PATIENT. THE MISSING PIECE WAS FOUND ON X-RAY IN THE PATIENT'S FASCIA, AND THE SURGEON WAS ABLE TO RETRIEVE IT". NO REPORT OF PATIENT HARM OR INJURY.
Additional Manufacturer Narrative
(B)(4).