MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS; ANASTOMOTIC COUPLER AND FLOW METER

Catalog Number ASKU

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2018

Event Type  malfunction  

Manufacturer Narrative

Product code and lot number given were: gem2754 and sp18e01-i303379 respectively, for a 3.0mm flow coupler.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that one of the pins of gem flow coupler was bent.This was noticed when the coupler was loaded on the anastomotic device.The coupler was replaced with another one without issue.This was noted during setup/preparation.There was no patient injury or medical intervention in association with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed, which revealed that one of the pins in the coupler was bent.The reported condition was verified.A device history review revealed no issues that could have caused or contributed to the reported issue.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: ANASTOMOTIC COUPLER AND FLOW METER
• 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: 7952386
• MDR Text Key: 123559181
• Report Number: 1416980-2018-06466
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 11/09/2018
• Supplement Dates FDA Received: 11/14/2018
• 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: Initial
• Patient Sequence Number: 1