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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY CUSHING RONGUER

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SYMMETRY SURGICAL INC SYMMETRY CUSHING RONGUER Back to Search Results
Model Number 57-2052
Device Problems Break (1069); Material Separation (1562); Device Fell (4014)
Patient Problem Insufficient Information (4580)
Event Date 09/09/2020
Event Type  malfunction  
Manufacturer Narrative
The customer submitted voluntary report# mw5096744. Symmetry received a copy of this report from the fda on 10/14/2020. Based on the lot number on the device, it was determined that the instrument was purchased in june 2019 and has therefore, been in use for over a year. Upon the initial evaluation of the returned instrument, it was noted that there was significant signs of wear and tear on the entire instrument and it was confirmed that the jaw of the instrument was broken off. The broken piece was returned with the device. Upon evaluation of the jaws, their appeared to be damage that is consistent with biting an object too hard or large for the device. The instrument was tested for hardness and it was confirmed to be within conformance per the product specifications and intended use. This is the first complaint that we have received for the product code of this nature with (b)(4) sold since 2012. This is an isolated event and nothing in our evaluation of the device determined that the damage occurred due to a defect in the manufacturing or material of the device. This damage was likely the cause of excessive stress on the jaws during use. Based on the above information, this can be seen as the final report. If additional information is obtained that alleges any additional patient involvement or need for corrective actions, a follow up report will be submitted.
 
Event Description
The jaw of the pituitary rongeur broke off and fell into the patient. The piece was retrieved with no harm to the patient.
 
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Brand NameSYMMETRY CUSHING
Type of DeviceRONGUER
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 Key10775076
MDR Text Key220757479
Report Number3007208013-2020-00032
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081651
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type user facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number57-2052
Device Catalogue Number57-2052
Device Lot Number120318
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2020
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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