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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL, INC. KERRISON RONGEUR RONGEUR, MANUAL

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SYMMETRY SURGICAL, INC. KERRISON RONGEUR RONGEUR, MANUAL Back to Search Results
Model Number 53-1512; 53-1515; 53-1518; 53-1533
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/15/2017
Event Type  malfunction  
Event Description
Once kerrison rongeurs inspected through maintenance company for cleaning, repairs and sharpening, the discovery of debris or possibly bio burden being retained after cleaning process and sterilization was brought to our knowledge. The debris or bio burden was found in the channel of the rongeur which is a closed system. There are drain holes in the bottom of the channel. The instrument is not routinely taken apart for sterilization and cleaning process. The instrument is only taken apart by the inspecting company.
 
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Brand NameKERRISON RONGEUR
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
SYMMETRY SURGICAL, INC.
3034 owen drive
antioch TN 37013
MDR Report Key6829872
MDR Text Key83961821
Report Number6829872
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model Number53-1512; 53-1515; 53-1518; 53-1533
Device Catalogue Number53-1512; 53-1515; 53-1518
Other Device ID NumberCAT NUMBER 53-1533; 2MM, 3MM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/24/2017
Event Location Hospital
Date Report to Manufacturer08/24/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/30/2017 Patient Sequence Number: 1
Treatment
KERRISON RONGEURS ARE PART OF INSTRUMENT SETS,THER
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