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U.S. Department of Health and Human Services

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

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SYNOVIS SURGICAL INNOVATIONS FLOW COUPLER DEVICE, ANASTOMOTIC, MICROVASCULAR Back to Search Results
Catalog Number 515101300010
Device Problem Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Date 09/04/2018
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported the connector teeth wires of a flow coupler were bent. This was noticed before patient use. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
The device was received for evaluation. The 3. 0mm flow coupler jaw assembly was received with the rings approximated, seated in the left jaw of the jaw assembly. Visual inspection revealed that the pins were bent. No functional testing could be completed; after the rings are approximated, they cannot be re-opened without significant damage to the rings. The reported condition was verified. The cause of the condition was not 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.
 
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Brand NameFLOW COUPLER
Type of DeviceDEVICE, 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 Key7927435
MDR Text Key122791844
Report Number1416980-2018-06281
Device Sequence Number1
Product Code MVR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132727
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515101300010
Device Lot NumberSP18B14-1272262
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2018
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

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