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

Catalog Number 5121-00400-060

Device Problems Unintended Ejection (1234); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when a coupler was deployed, the ring and base with post slid out of the instrument, instead of the ring only being deployed.This issue was identified during a surgical procedure on a patient.To resolve the issue, the coupler was removed from the patient¿s vessel and it was successfully replaced with a second device.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information : the device was received for evaluation.Both the jaw assembly and the coupler rings were returned for investigation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.No functional testing could be completed on the coupler rings.The jaw assembly was placed in an anastomotic instrument (ai).An audible click was heard when the assembly was placed in the ai which indicates the assembly was locked into place.No other functional testing of the jaw assembly was required.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9180138
• MDR Text Key: 162490440
• Report Number: 1416980-2019-05565
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

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: Health Professional
• Device Catalogue Number: 5121-00400-060
• Device Lot Number: SP15I25-1082349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 11/01/2019
• Supplement Dates FDA Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1