MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-04-10 for GEM FLOW COUPLER DEVICE AND SYSTEM GEM2754-FC NA manufactured by Synovis Surgical Innovations.
[5718078]
It was reported that a gem 3. 0 mm flow-coupler experienced ring separation during pharyngeal reconstruction free flap surgery after it had been placed on the patient. The flow-coupler rings were adequately removed and a new gem flow-coupler was used to complete the anastomosis. No significant additional ischemia time was reported. No adverse patient outcome was reported.
Patient Sequence No: 1, Text Type: D, B5
[13134701]
The device history record for this lot number was reviewed. One hundred percent 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. The ring separation force is within specification. According to the device history record, the device met specification prior to market release. The wing jaw assembly and doppler probe were returned for evaluation. The flow-coupler rings were not returned. The device was visually inspected under 10x-50x magnification. Organic material was observed on the wing jaw. The left and right wings were manually brought together. The wing jaw assembly functioned normally. The doppler probe appeared normal. The doppler probe was not functionally tested. There is no immediate evidence to support why the rings did not stay together. No additional information is available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183620-2015-00002 |
| MDR Report Key | 4683912 |
| Report Source | 05,07 |
| Date Received | 2015-04-10 |
| Date of Report | 2015-03-10 |
| Date of Event | 2015-03-10 |
| Date Mfgr Received | 2015-03-10 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2015-05-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SCOTT JOHNSON |
| Manufacturer Street | 2575 UNIVERSITY AVE. |
| Manufacturer City | ST. PAUL MN 551141024 |
| Manufacturer Country | US |
| Manufacturer Postal | 551141024 |
| Manufacturer Phone | 6517967334 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEM FLOW COUPLER DEVICE AND SYSTEM |
| Generic Name | ANASTOMOTIC COUPLER AND FLOW METER |
| Product Code | DPW |
| Date Received | 2015-04-10 |
| Model Number | GEM2754-FC |
| Catalog Number | NA |
| Lot Number | SPSGT15-01A0007 |
| ID Number | NA |
| Device Expiration Date | 2017-01-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Address | 2575 UNIVERSITY AVE. ST. PAUL MN 55114 US 55114 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-10 |