FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP** ENDOSCOPIC APPLIER
MDR report key: 3002706
·
Received March 13, 2013
Report
- Report Number
- 3005075853-2013-01243
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Date of Event
- March 4, 2013
- Report Date
- March 4, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- HBT
- PMA / PMN Number
- K830503
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
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 AN UNKNOWN PROCEDURE, THE APPLIER FAILED TO CLAMP DOWN THE CLIPS SUFFICIENTLY. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. NO PATIENT IMPACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105529 | LIGACLIP** ENDOSCOPIC APPLIER | APPLIER, HEMOSTATIC CLIP | HBT | ETHICON ENDO-SURGERY, LLC. | NA | NA | |
| 105530 | LIGACLIP** ENDOSCOPIC APPLIER | APPLIER, HEMOSTATIC CLIP | HBT | ETHICON ENDO-SURGERY, LLC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |