FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP SINGLE CLIP APPLIER
MDR report key: 329683
·
Received April 20, 2001
Report
- Report Number
- 1527736-2001-02001
- Event Type
- Malfunction
- Date Received
- April 20, 2001
- Date of Event
- March 19, 2001
- Report Date
- March 21, 2001
- Manufacturer
- POST SURGICAL MFG
- Product Code
- FZP
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT CLIP MALFORMED AND CUT A VEIN DURING A CORONARY ARTERY BYPASS GRAFT. THE VEIN WAS CAUTERIZED. COMPETITOR'S DEVICE COMPLETED CASE. NO FURTHER PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18241 | LIGACLIP SINGLE CLIP APPLIER | CLIP APPLIERS - CONVENTIONAL/REUSAB | FZP | POST SURGICAL MFG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |