FDA Adverse Event
Malfunction
Summary report: N
WECK HOL L CLIPS
MDR report key: 1033155
·
Received April 23, 2008
Report
- Report Number
- 3003898360-2008-00018
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- March 27, 2008
- Report Date
- April 3, 2008
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- FZP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SAMPLES HAVE BEEN REC'D AND ARE UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINT REPORTED: "THE CLIPS SHATTERED DURING APPLICATION TO THE CYSTIC DUCT DURING A LAPAROSCOPIC CHOLECYSTECTOMY." NO PT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFO OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WECK HOL L CLIPS | LIGATING CLIPS | FZP | TELEFLEX MEDICAL | T1270227 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |