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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY GORNEY; SCISSOR
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SYMMETRY SURGICAL INC. SYMMETRY GORNEY; SCISSOR Back to Search Results
Model Number 32-992
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/09/2015
Event Type  No Answer Provided  
Event Description
The tip of the scissor has broken off.After examination of the scissor the break has occurred at the weld of the tungsten carbide and the steel of the scissors, this break appears to very clean.Patient was x-rayed, no pieces remained.Not sure where or when the break occurred.No patient injury.
 
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Brand Name
SYMMETRY GORNEY
Type of Device
SCISSOR
Manufacturer (Section D)
SYMMETRY SURGICAL INC.
3034 owen dr
antioch TN 37013
Manufacturer (Section G)
SYMMETRY SURGICAL INC.
3034 owen dr
antioch TN 37013
Manufacturer Contact
victoria rogers
3034 owen dr
antioch, TN 37013
8002513000
MDR Report Key5197238
MDR Text Key31076537
Report Number3007208013-2015-00028
Device Sequence Number1
Product Code LRW
UDI-Device Identifier00887482072004
UDI-Public00887482072004
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date 10/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number32-992
Device Catalogue Number32-992
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/09/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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