FDA Adverse Event
Malfunction
Summary report: N
GEM MICROVASCULAR ANASTOMOTIC COUPLER
MDR report key: 2579718
·
Received May 10, 2012
Report
- Report Number
- 2183620-2012-00049
- Event Type
- Malfunction
- Date Received
- May 10, 2012
- Report Date
- April 10, 2012
- Manufacturer
- SYNOVIS SURGICAL INNOVATIONS
- Product Code
- MVR
- PMA / PMN Number
- K861985
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE COUPLER DEVICES INVOLVED IN THE INCIDENT WERE NOT RETURNED FOR EVAL, AND THEREFORE, FUNCTIONAL TESTING COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. SAME REPORTER AS THE FOLLOWING MANUFACTURER REPORT NUMBERS, BUT SEPARATE EVENTS: 2183620-2012-00047, 2183620-2012-00048, 2183620-2012-00049, 2183620-2012-00050.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE 2.0MM COUPLER DURING A FIBULA FREE FLAP. THE RING CAME APART. THE ANASTOMOSIS WAS SUTURED BY HAND. NO FURTHER DETAILS ARE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEM MICROVASCULAR ANASTOMOTIC COUPLER | ANASTOMOTIC COUPLER | MVR | SYNOVIS SURGICAL INNOVATIONS | GEM2752 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |