FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL
MDR report key: 1070580
·
Received July 2, 2008
Report
- Report Number
- 3005075853-2008-00258
- Event Type
- Malfunction
- Date Received
- July 2, 2008
- Date of Event
- June 9, 2008
- Report Date
- June 10, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- FZP
- PMA / PMN Number
- K864102
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 7/2/08. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP. CHOLECYSTECTOMY PROCEDURE, THE CLIPS FLEW AWAY FROM THE JAWS INTO THE PT. THE CLIPS WERE RECOVERED FROM THE PT. THE CASE WAS COMPLETED WITH THE SAME LIKE DEVICE. THERE WAS NO ADVERSE PT CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL | FZP | ETHICON ENDO-SURGERY, LLC | NA | D4HY20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |