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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REP, DYONICS POWER II CONTROL UNIT ARTHROSCOPE

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SMITH & NEPHEW, INC. SVCE REP, DYONICS POWER II CONTROL UNIT ARTHROSCOPE Back to Search Results
Catalog Number 72200873S
Device Problems Melted (1385); Device Emits Odor (1425); Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/12/2016
Event Type  malfunction  
Event Description
It was reported that during the procedure, the device heated and the plastic melted into the hand piece and a burnt smell was noted. A back-up device was available to complete the procedure. No reported patient injuries. No other complications were noted.
 
Manufacturer Narrative
There was no relationship found between the returned device and the reported incident. A visual inspection of the device found wear marks on the cover. Functional evaluation did not identify any issues. The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the functional testing process. Factors, unrelated to the design or manufacture of the device that could have contributed to the complaint event, include an issue with the concomitant devices used with the controller. After the evaluation there was no root cause for the reported issue and the device performed within the expected parameters. There are no indications that would suggest that the device did not meet product specifications upon release into distribution.
 
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Brand NameSVCE REP, DYONICS POWER II CONTROL UNIT
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
james gonzales
7000 w. william cannon
austin, TX 78735
5123585706
MDR Report Key6066754
MDR Text Key59057645
Report Number1643264-2016-00200
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200873S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2013
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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