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U.S. Department of Health and Human Services

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

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SYNOVIS SURGICAL INNOVATIONS ANASTOMOTIC COUPLER AND FLOW METER Back to Search Results
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.
 
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Brand NameNI
Type of DeviceANASTOMOTIC 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 Key7952386
MDR Text Key123559181
Report Number1416980-2018-06466
Device Sequence Number1
Product Code MVR
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
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

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