MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS GEM MICROVASCULAR ANASTOMOTIC COUPLER; GEM COUPLER

Model Number GEM2754

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

User facility report #: (b)(4).The device was not returned for evaluation.The dhr was obtained and reviewed.The lot passed visual and functional inspection.The results noted in the dhr for coupler separation force is within specification.The ring retention force test results noted in the dhr are within specification.100% functional alignment testing was performed on each device during the manufacturing process.In addition, 100% visual inspection for broken or missing parts was performed.The released product met specification.During follow up with the hospital it has been discovered that the device was not used and was discarded.Another gem 3.0mm coupler was used to complete the anastomosis.Patient outcome was good.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported by uf/importer report # (b)(4) that a gem microvascular anastomotic coupler operated differently than expected.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: GEM MICROVASCULAR ANASTOMOTIC COUPLER
• Type of Device: GEM COUPLER
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; saint paul MN
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55144
• Manufacturer Contact: your company street; your company town, IL 99999 ; 2242702068
• MDR Report Key: 6181614
• MDR Text Key: 62679996
• Report Number: 1416980-2016-18440
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2021
• Device Model Number: GEM2754
• Device Catalogue Number: 515101300010
• Device Lot Number: SP16C26-1136162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR