FDA Adverse Event
Malfunction
Summary report: N
ROTATING MULTIPLE CLIP APPLIER
MDR report key: 3873712
·
Received June 16, 2014
Report
- Report Number
- 3005075853-2014-04010
- Event Type
- Malfunction
- Date Received
- June 16, 2014
- Date of Event
- May 15, 2014
- Report Date
- May 20, 2014
- 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
- TC
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS MALFORMATION OF THE CLIPS FOR THE CLIP APPLIER AND IN EVERY FOURTH OR FIFTH TIME OF FIRING, THE CLIPS STARTS "LOSING AND FALLING OFF." NO PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352374 | ROTATING MULTIPLE CLIP APPLIER | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |