FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM
MDR report key: 2112034
·
Received June 2, 2011
Report
- Report Number
- 3005075853-2011-02270
- Event Type
- Malfunction
- Date Received
- June 2, 2011
- Report Date
- May 11, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- FZP
- PMA / PMN Number
- K050344
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE DEVICE LOCKED ON TISSUE. THE DEVICE WOULD NOT OPEN. THE SURGEON PULLED THE DEVICE OFF TISSUE WITH MINIMAL TISSUE DAMAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX-5MM | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |