WECK HZ APPLIER SMALL 6" CVD
Report
- Report Number
- 3011137372-2025-00020
- Event Type
- Malfunction
- Date Received
- January 8, 2025
- Date of Event
- December 23, 2024
- Report Date
- December 23, 2024
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GDO
- UDI-DI
- 34026704622598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN#(B)(4). THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED: "PER CUSTOMER PROVIDED INFORMATION THE DHR FOR THE ALLEGED DEFECTIVE MEDICAL DEVICE WAS REVIEWED AND FOUND COMPLETE WITHOUT ANY IRREGULARITIES. THE ALLEGED DEFECTIVE INSTRUMENT WAS PRODUCED AT THE TECOMET, INC. KENOSHA, WI FACILITY AS PART OF A (B)(4) PC LOT IN OCTOBER OF 2021. IT WAS FOUND THAT THIS ORDER WAS MADE FROM THE CORRECT MATERIALS AND COMPONENTS, AND ALL APPROVED PROCESSES WERE FOLLOWED. AFTER A VISUAL AND FUNCTIONAL INSPECTION WAS CONDUCTED, IT WAS CONCLUDED THE JAWS ARE ALIGNED AND ARE FUNCTIONING CORRECTLY. ALL (B)(4) INSTRUMENTS FROM THIS LOT WERE 100% VISUALLY INSPECTED AND FUNCTION TESTED PRIOR TO SHIPMENT TO THE CUSTOMER AS THIS IS A STANDARDIZED PROCEDURE AT THIS FACILITY FOR THIS PRODUCT LINE. DUE TO THESE FINDINGS, NO FURTHER ACTIONS WILL BE TAKEN IN RESPONSE TO THIS COMPLAINT AND THIS RECORD WILL BE DEEMED CLOSED. ALL 100 INSTRUMENTS FROM THIS LOT WERE 100% VISUALLY INSPECTED AND FUNCTION TESTED PRIOR TO SHIPMENT TO THE CUSTOMER AS THIS IS A STANDARDIZED PROCEDURE AT THIS FACILITY FOR THIS PRODUCT LINE. DUE TO THESE FINDINGS, NO FURTHER ACTIONS WILL BE TAKEN IN RESPONSE TO THIS COMPLAINT AND THIS RECORD WILL BE DEEMED CLOSED." TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.
(B)(4). THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED: "PER CUSTOMER PROVIDED INFORMATION THE DHR FOR THE ALLEGED DEFECTIVE MEDICAL DEVICE WAS REVIEWED AND FOUND COMPLETE WITHOUT ANY IRREGULARITIES. THE ALLEGED DEFECTIVE INSTRUMENT WAS PRODUCED AT THE TECOMET, INC. KENOSHA, WI FACILITY AS PART OF A 100-PC LOT IN OCTOBER OF 2021. IT WAS FOUND THAT THIS ORDER WAS MADE FROM THE CORRECT MATERIALS AND COMPONENTS, AND ALL APPROVED PROCESSES WERE FOLLOWED. THIS INSTRUMENT HAS NOT BEEN RETURNED FOR REVIEW OR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE ALLEGED DEFECT OR VALIDATE THE ALLEGED COMPLAINT. ALL 100 INSTRUMENTS FROM THIS LOT WERE 100% VISUALLY INSPECTED AND FUNCTION TESTED PRIOR TO SHIPMENT TO THE CUSTOMER AS THIS IS A STANDARDIZED PROCEDURE AT THIS FACILITY FOR THIS PRODUCT LINE. DUE TO THESE FINDINGS, NO FURTHER ACTIONS WILL BE TAKEN IN RESPONSE TO THIS COMPLAINT AND THIS RECORD WILL BE DEEMED CLOSED." TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.
(B)(4) .
IT WAS REPORTED THAT "THE APPLIER JAWS WERE FOUND MISALIGNED BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD".
IT WAS REPORTED THAT "THE APPLIER JAWS WERE FOUND MISALIGNED BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD".
IT WAS REPORTED THAT "THE APPLIER JAWS WERE FOUND MISALIGNED BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1641237 | WECK HZ APPLIER SMALL 6" CVD | APPLIER, SURGICAL, CLIP | GDO | TELEFLEX MEDICAL | 06K2140835 | 34026704622598 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |