FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP MCA LARGE APPLIER
MDR report key: 1070642
·
Received July 1, 2008
Report
- Report Number
- 3005075853-2008-00232
- Event Type
- Malfunction
- Date Received
- July 1, 2008
- Date of Event
- June 10, 2008
- Report Date
- June 10, 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
- LA, US
- 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 HEMICOLECTOMY, THE DEVICE PRODUCED PEAR SHAPED CLIPS. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP MCA LARGE APPLIER | GDO | ETHICON ENDO-SURGERY, LLC. | NA | E4KU76 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |