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

Catalog Number 511100200060

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the pins of a coupler were observed to have broken off the ring.The coupler pins broke off during an unspecified procedure.Another coupler was used without incident.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

A device history review revealed no issues that could have caused or contributed to the reported issue.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: COUPLER
• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; saint paul MN
• MDR Report Key: 8901239
• MDR Text Key: 155622086
• Report Number: 1416980-2019-04470
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 511100200060
• Device Lot Number: SP19F06-1377918
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1