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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616S
Device Problems Device Stops Intermittently (1599); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the svc repl,mdu, hand cntrl, pwrmx would start then stop sporadically and the cord was also hot at connection. This occurred during the procedure. There was a delay of less than 30 minutes. A backup device was readily available to complete the procedure. No patient injuries were reported.
 
Manufacturer Narrative
Device investigation narrative - unit was powered on using the appropriate test equipment and it failed functional tests with intermittent current draw and grinding noise. Power cord assembly grew warm during testing. After troubleshooting, the cause of failure was observed to be a defective power cord assembly. A visual inspection was performed on the power cords external covering and no physical damage was observed, only cosmetic. The motor and hall board were tested and passed functional testing. The investigation has concluded that the power cord has a shorted or open internal wire. Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include normal wear and tear, causing damage as a result of consistent use over time such as excessive tensile stress applied to the power cord, which could have partially broken one or more signal wires. A review of the manufacturing records shows this unit was released to distribution as a service replacement on or about may 08, 2014. The mdu is over 4 years old and power cord has never been replaced. No containment or corrective actions are recommended at this time.
 
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Brand NameSVC REPL,MDU, HAND CNTRL, PWRMX
Type of DeviceSAW, POWERED, AND ACCESSORIES
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
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key6285803
MDR Text Key66328346
Report Number1643264-2017-00059
Device Sequence Number1
Product Code HAB
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616S
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 Received02/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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