FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL
MDR report key: 1070661
·
Received July 1, 2008
Report
- Report Number
- 3005075853-2008-00243
- Event Type
- Malfunction
- Date Received
- July 1, 2008
- Date of Event
- June 10, 2008
- Report Date
- June 12, 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
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 07/01/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SIGMOIDECTOMY PROCEDURE, JAMMING OCCURRED AND THE CLIP FELL OUT FROM THE JAW. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |