FDA Adverse Event
Malfunction
Summary report: N
GEM MICROVASCULAR ANASTOMOTIC COUPLER
MDR report key: 2972250
·
Received February 15, 2013
Report
- Report Number
- 2183620-2013-00003
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Report Date
- January 18, 2013
- Manufacturer
- SYNOVIS SURGICAL INNOVATIONS
- Product Code
- MVR
- PMA / PMN Number
- K861985
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LOT NUMBER IS UNAVAILABLE FOR REVIEW OF DEVICE HISTORY RECORD. A 100% FUNCTIONAL ALIGNMENT TESTING IS PERFORMED ON EACH DEVICE AND 100% VISUAL INSPECTION FOR BROKEN OR MISSING PARTS AND PIN ALIGNMENT IS PERFORMED ON EACH ASSEMBLY DURING THE MANUFACTURING PROCESS. SAME REPORTER AS THE FOLLOWING MANUFACTURER REPORT NUMBERS: 2183620-2013-00001, 2183620-2013-00002.
Description of Event or Problem · 1
IT WAS REPORTED THAT COUPLER PINS DID NOT COME TOGETHER PROPERLY ON A COUPLER DEVICE. THE DEVICE WAS NOT IMPLANTED. ANOTHER COUPLER WAS USED FOR THE ANASTOMOSIS. NO PT INJURY WAS REPORTED. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69632 | GEM MICROVASCULAR ANASTOMOTIC COUPLER | ANASTOMOTIC COUPLER | MVR | SYNOVIS SURGICAL INNOVATIONS | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |