FDA Adverse Event
Malfunction
Summary report: N
COMPRESSION ANASTOMOSIS RING (CAR 27)
MDR report key: 2064008
·
Received March 23, 2011
Report
- Report Number
- 3005278776-2011-00015
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- February 22, 2011
- Report Date
- February 23, 2011
- Manufacturer
- NITI SURGICAL SOLUTIONS, LTD.
- Product Code
- FZP
- PMA / PMN Number
- K062008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NITI SURGICAL SOLUTIONS (B)(4)) AND THE IMPORTER (B)(4), AS NITI SURGICAL SOLUTIONS LTD. SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION; HOWEVER, THE PRODUCTION HISTORY FILES INDICATED THAT THE DEVICE WAS RELEASED PURSUANT TO THE PRODUCT SPECIFICATIONS. THE RED MARKER HAS NO IMPACT UPON DEVICE SAFETY AND PERFORMANCE AND THUS THE OUTCOME OF THE PROCEDURE. IT ONLY SERVES AS AN ADDITIONAL INDICATION OF THE SEQUENTIAL STATUS OF DEVICE OPERATION.
Description of Event or Problem · 1
AFTER FIRING THE COLONRING DEVICE, THE KNOB INDICATOR FELL DOWN. THE SURGEON DIDN'T HEAR CLICK SOUND WHEN HE TURNED THE OPERATING KNOB CLOCKWISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPRESSION ANASTOMOSIS RING (CAR 27) | IMPLANTABLE CLIP (FZP) | FZP | NITI SURGICAL SOLUTIONS, LTD. | CAR 27 | 43271220T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |