FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP*MCA MED APPLIER
MDR report key: 3002613
·
Received March 13, 2013
Report
- Report Number
- 3005075853-2013-01242
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Date of Event
- February 4, 2013
- Report Date
- March 1, 2013
- 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
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: MULTIPLE REQUEST FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON APPLIED CLIP TO VESSEL AND THE TIPS OF THE CLIP CROSSED INSTEAD OF MEETING TO LIGATE THE VESSEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105965 | LIGACLIP*MCA MED APPLIER | CLIP, IMPLANTABLE | GDO | ETHICON ENDO-SURGERY, LLC. | NA | K4C086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |