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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY TENZOR CARBON FIBER TRACTION UNIT ASSEMBLY SURGICAL TABLE ACCESSORY

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STERIS CORPORATION - MONTGOMERY TENZOR CARBON FIBER TRACTION UNIT ASSEMBLY SURGICAL TABLE ACCESSORY Back to Search Results
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2016
Event Type  No Answer Provided  
Manufacturer Narrative
A steris account manager arrived onsite, inspected the assembly, and identified that the boot straps ripped/tore. It is most likely that the or staff over tightened the straps causing them to rip/tear. The account manager replaced the boot straps, tested the assembly, and confirmed it to be operating according to specification. The assembly was returned for customer use. No additional issues have been reported. Section 1 of the operator manual for the tenzor carbon fiber traction unit assembly states, "check the table orthopedic extension abductor bars, siderails and carbon fiber traction unit for possible damage or wear prior to each use. Do not use the carbon fiber traction unit if any damage is apparent, if parts are missing or if it does not operate as expected. ".
 
Event Description
The user facility reported that the boot strap on their tenzor carbon fiber traction unit assembly broke during a patient procedure. No report of injury, however the procedure was delayed due to the reported event.
 
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Brand NameTENZOR CARBON FIBER TRACTION UNIT ASSEMBLY
Type of DeviceSURGICAL TABLE ACCESSORY
Manufacturer (Section D)
STERIS CORPORATION - MONTGOMERY
2720 gunter park drive east
montgomery AL 36109
Manufacturer (Section G)
STERIS CORPORATION - MONTGOMERY
2720 gunter park drive east
montgomery AL 36109
Manufacturer Contact
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key5492569
MDR Text Key40337773
Report Number1043572-2016-00021
Device Sequence Number1
Product Code JEB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2016
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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