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

Model Number GEM2753

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a gem2753 coupler did not close during surgery.This was an ent procedure on a male (b)(6).The surgeon used another coupler to finish the procedure.The patient is doing well.No adverse outcome was reported.It is not known when the product defect was observed.

Manufacturer Narrative

Device history record review was completed.No irregularities were found when reviewing supplier records.The coupler ring separation testing was competed at the supplier with passing results.The 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.Ring retention testing was completed at incoming inspection with passing results.The released product met specification.One 2.5mm gem coupler device was returned for evaluation.Both of the coupler rings, the wing jaw assembly, and the protective sheath were evaluated.The rings were examined under magnification.It is unknown if the user fully squeezed the rings together.The surface of the rings do not have extraneous marks indicating that the rings came together misaligned.There is one distorted pin that would prevent the rings from coming together properly.Other details of the event could not be verified and the ring appears to meet specifications.No functional testing was performed on the coupler rings.Once the rings have been inserted into the jaw assembly and removed, the ring retention force inside the jaw assembly is reduced when inserted and removed a second time.In addition, with the bent pin on the one ring, the separation force could not be performed because the rings will not align properly.The wing jaw assembly containing no rings was placed onto a test anastomotic instrument.The instrument was cycled and the left and right wings approximated correctly.The failure mode as reported "coupler would not close" could not be verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: GEM MICROVASCULAR ANASTOMOTIC COUPLER
• Type of Device: ANASTOMOTIC 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: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6018379
• MDR Text Key: 57047008
• Report Number: 1416980-2016-16154
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GEM2753
• Device Catalogue Number: 511100250060
• Device Lot Number: SNSP15F18-1056780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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: 64 YR