FDA Adverse Event
Malfunction
Summary report: N
ROTATING MULTIPLE CLIP APPLIER
MDR report key: 2032032
·
Received March 28, 2011
Report
- Report Number
- 3005075853-2011-01230
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- February 28, 2011
- Report Date
- February 28, 2011
- 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
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). JAWS, SHROUD.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP APPLIER WORKED WELL FOR THE FIRST COUPLE OF CLIPS. THE LAST CLIPS WERE NOT FORMED AT ALL. THE DEVICE COULD BE FIRED; CLIPS WERE APPLIED BUT NOT FORMED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROTATING MULTIPLE CLIP APPLIER | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | H4344J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |