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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS COUPLER; DEVICE, ANASTOMOTIC, MICROVASCULAR
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SYNOVIS SURGICAL INNOVATIONS COUPLER; DEVICE, ANASTOMOTIC, MICROVASCULAR Back to Search Results
Catalog Number 511100300060
Device Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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.
 
Event Description
This report summarizes 1 malfunction events.It was reported that a 3mm coupler had a ring mismatch and was unable to close.This occurred at the hospital during treatment.To resolve the issue, the product was replaced and treatment was continued.The patient was not in contact with the product.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
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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 Key8841313
MDR Text Key152681004
Report Number1416980-2019-04163
Device Sequence Number1
Product Code MVR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial
Report Date 07/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number511100300060
Device Lot NumberSP18F20-1311845
Date Manufacturer Received06/30/2019
Type of Device Usage N
Patient Sequence Number1
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