FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP** ENDOSCOPIC
MDR report key: 1933409
·
Received December 20, 2010
Report
- Report Number
- 3005075853-2010-07274
- Event Type
- Malfunction
- Date Received
- December 20, 2010
- Report Date
- November 29, 2010
- 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
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING INFORMATION WAS REQUESTED, BUT NO FURTHER DETAILS COULD BE PROVIDED: (B)(4). THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE SCISSORING OR NOT COMPLETELY FORMING. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY IMPAC6T TO THE PATIENT. NO OTHER DETAILS WERE PROVIDED. NO RETURN DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP** ENDOSCOPIC | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |