FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP MCA MED APPLIER
MDR report key: 1070570
·
Received July 2, 2008
Report
- Report Number
- 3005075853-2008-00263
- Event Type
- Malfunction
- Date Received
- July 2, 2008
- Date of Event
- June 10, 2008
- Report Date
- June 11, 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
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, CLIPS WOULD NOT HOLD AFTER PLACING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO PT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP MCA MED APPLIER | GDO | ETHICON ENDO-SURGERY, LLC | NA | E4KV7P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |