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U.S. Department of Health and Human Services

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

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SYMMETRY SURGICAL INC SYMMETY SHARP KERRISON KERRISON RONGEUR Back to Search Results
Catalog Number 53-1675
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2019
Event Type  malfunction  
Manufacturer Narrative
This instrument was purchased in 2017. An rma has been issue for the customer to return the instrument for evaluation. A follow-up report will be submitted once the device has been evaluated.
 
Event Description
The sharp kerrison handle was used in combination with the single use tips (53-1664), the tip was placed into the device correctly making sure to hear the click. While the surgeon was making his first cuts in the patient, a piece from the locking mechanism broke off. The piece was removed from the patient with no harm.
 
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Brand NameSYMMETY 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 Key9491990
MDR Text Key199328129
Report Number3007208013-2019-00036
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K130541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number53-1675
Device Lot Number1546186
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2019
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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