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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY SHARP KERRISON KERRISON RONGEUR

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SYMMETRY SURGICAL INC SYMMETRY SHARP KERRISON KERRISON RONGEUR Back to Search Results
Catalog Number 53-1675
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
The product is being returned on an rma but has not been received yet. The customer has not provided details on each event including event dates. There have been a total of (b)(4) sold of all lots of this product code with 16 complaints recorded for similar occurrences. The last reported complaint for this occurrence was in (b)(6) 2019. A follow up report will be submitted once we have received additional information and evaluated the product.
 
Event Description
In the last two weeks, three sharp kerrison handles snapped in the same place on the locking mechanism during a procedure. In each procedure, the kerrison broke in the two hour range of the procedure using single use tips.
 
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Brand NameSYMMETRY SHARP KERRISON
Type of DeviceKERRISON RONGEUR
Manufacturer (Section D)
SYMMETRY SURGICAL INC
3034 owen drive
antioch TN 37013
Manufacturer (Section G)
SYMMETRY SURGICAL INC
3034 owen drive
antioch TN 37013
Manufacturer Contact
brandi meath
3034 owen drive
antioch, TN 37013
6159645290
MDR Report Key11114055
MDR Text Key226093631
Report Number3007208013-2021-00003
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number53-1675
Device Lot Number1600651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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