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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY LOVE-GRUENWALD SPURLING IVD RONGEUR

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SYMMETRY SURGICAL INC SYMMETRY LOVE-GRUENWALD SPURLING IVD RONGEUR Back to Search Results
Catalog Number 53-1240
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/17/2018
Event Type  malfunction  
Manufacturer Narrative
The outcome of the patient, lot number, and age of the instrument are unknown. Multiple attempts have been made for additional information. We will continue to try for additional information. A follow-up report will be submitted once we gain additional information. There has been a total of (b)(4) sold since 2012 with no additional complaints recorded.
 
Event Description
On (b)(6) 2018 during an unknown procedure, a disc rongeur broke its gripper inside the patient. X-rays were performed many times in order to monitor the event. There were seven unsuccessful attempts performed using a microscope to remove the broken fragment/s. It is unknown how the procedure was completed.
 
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Brand NameSYMMETRY LOVE-GRUENWALD
Type of DeviceSPURLING IVD RONGEUR
Manufacturer (Section D)
SYMMETRY SURGICAL INC
3034 owen drive
antioch TN 37013
Manufacturer (Section G)
SYMMETRY SURGICIAL INC
3034 owen drive
antioch TN 37013
Manufacturer Contact
brandi meath
3034 owen drive
antioch, TN 37013
6159645290
MDR Report Key8769377
MDR Text Key150443083
Report Number3007208013-2019-00026
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 07/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number53-1240
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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