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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION COUPLER DEVICE, ANASTOMOTIC, MICROVASCULAR

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BAXTER HEALTHCARE CORPORATION COUPLER DEVICE, ANASTOMOTIC, MICROVASCULAR Back to Search Results
Catalog Number 511100100010
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Patient Involvement (2645)
Event Date 07/31/2020
Event Type  malfunction  
Manufacturer Narrative
The 1. 0mm coupler jaw assembly was received for evaluation. Visual inspection revealed that the 1. 0mm ring was missing (dislodged) from the left jaw and the ring was properly seated in the right jaw. The cause of the condition could not be determined. Potential contributing causes could be inadvertent ring dislodgement during shipment to the customer or removal of the white plastic holder in preparation for the surgical process. 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.
 
Event Description
During evaluation of a returned 1. 0mm coupler jaw assembly, the ring from the left jaw was found to be missing and the ring from the right jaw was intact. There was no patient involvement. No additional information is available.
 
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Brand NameCOUPLER
Type of DeviceDEVICE, ANASTOMOTIC, MICROVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
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 Key10609686
MDR Text Key209334855
Report Number1416980-2020-06104
Device Sequence Number1
Product Code MVR
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K861985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number511100100010
Device Lot NumberSP19F06-1377925
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2020
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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