HZ APPLIER MICRO 6" CVD
Report
- Report Number
- 3011137372-2022-00082
- Event Type
- Injury
- Date Received
- May 20, 2022
- Date of Event
- December 1, 2021
- Report Date
- April 25, 2022
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GDO
- UDI-DI
- 24026704696639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THE DEVICE INVESTIGATION IS PENDING.
(B)(4). THE DHR FOR THE RETURNED INSTRUMENT WAS REVIEWED AND FOUND COMPLETELY WITHOUT ANY IRREGULARITIES. THIS INSTRUMENT WAS PRODUCED AT THE TELEFLEX MEDICAL KENOSHA, WI FACILITY AS PART OF A (B)(4)-PIECE LOT IN SEPTEMBER OF 2010. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT THE JAWS ARE ALIGNED WITH EACH OTHER IN THE CLOSED POSITION. FUNCTIONAL TESTING SHOWS THAT THIS INSTRUMENT WAS ABLE TO PICK-UP, RETAIN, CLOSE AND RELEASE MULTIPLE CLIPS WITHOUT ANY ISSUES. WE ARE UNABLE TO REPLICATE THE ALLEGED ISSUE THEREFORE WE ARE UNABLE TO VALIDATE THIS COMPLAINT. ALL 90 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.
WHEN CLOSING VESSEL WITH MICROCLIP VESSEL IS CUT.
WHEN CLOSING VESSEL WITH MICROCLIP VESSEL IS CUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2577797 | HZ APPLIER MICRO 6" CVD | APPLIER, SURGICAL, CLIP | GDO | TELEFLEX MEDICAL | IPN008962 | 06B1020157 | 24026704696639 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |