FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP MCA MED LONG APPLIER
MDR report key: 1190752
·
Received October 7, 2008
Report
- Report Number
- 3005075853-2008-02156
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 3, 2008
- Report Date
- September 16, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDO
- PMA / PMN Number
- K820837
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A MODIFIED RADICAL MASTECTOMY PROCEDURE, THE SURGEON HAD COMPLETED APPROXIMATELY TEN FIRINGS, THE NEXT CLIP TRANSECTED THE VESSEL RATHER THAN SEALING IT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP MCA MED LONG APPLIER | GDO | ETHICON ENDO-SURGERY, LLC | NA | E4LA7E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |