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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS COUPLER ACCESSORIES; FORCEPS
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SYNOVIS SURGICAL INNOVATIONS COUPLER ACCESSORIES; FORCEPS Back to Search Results
Catalog Number 5193-06001-010
Device Problem Corroded (1131)
Patient Problem No Patient Involvement (2645)
Event Date 01/07/2019
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that rust was observed on a pair of coupler forceps.The rust was discovered prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The device was received for evaluation.A visual inspection was performed and it was noted that the forceps had brownish/orange discoloration.The reported condition was verified.The cause of the reported condition was undetermined.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 Name
COUPLER ACCESSORIES
Type of Device
FORCEPS
Manufacturer (Section D)
SYNOVIS SURGICAL INNOVATIONS
saint paul MN
MDR Report Key8310918
MDR Text Key135190481
Report Number1416980-2019-00615
Device Sequence Number1
Product Code HTD
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5193-06001-010
Device Lot Number74855
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2019
Date Manufacturer Received02/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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