FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP** ENDOSCOPIC CLIP APPLIER
MDR report key: 3121728
·
Received May 21, 2013
Report
- Report Number
- 3005075853-2013-02444
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Date of Event
- April 25, 2013
- Report Date
- April 25, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- FZP
- PMA / PMN Number
- K864102
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE DID NOT FORM CLIPS CORRECTLY. NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223927 | LIGACLIP** ENDOSCOPIC CLIP APPLIER | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |