FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP** ENDOSCOPIC
MDR report key: 1930220
·
Received December 16, 2010
Report
- Report Number
- 3005075853-2010-07201
- Event Type
- Malfunction
- Date Received
- December 16, 2010
- Date of Event
- November 23, 2010
- Report Date
- November 25, 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
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE, NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.
Additional Manufacturer Narrative · 1
(B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE NOT IN REGULAR FORM. THEY COME OUT AS TWISTED. ALSO, WHEN THE DOCTOR FIRED THE DEVICE, MORE THAN ONE CLIP CAME OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP** ENDOSCOPIC | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | G4T917 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |