FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP MCA MULTIPLE CLIP APPLIER - 23.8 CM, 20 MEDIUM
MDR report key: 1810071
·
Received November 13, 2007
Report
- Report Number
- 1527736-2007-07598
- Event Type
- Malfunction
- Date Received
- November 13, 2007
- Date of Event
- August 13, 2007
- Report Date
- October 24, 2007
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GDO
- PMA / PMN Number
- K820837
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A VASCULAR SURGERY, THE CLIPS WILL NOT HOLD. COMPLETED WITH THE SAME LIKE PRODUCT. THERE WAS NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP MCA MULTIPLE CLIP APPLIER - 23.8 CM, 20 MEDIUM | GDO | ETHICON ENDO-SURGERY, INC. | NA | D4H73L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |