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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 Overheating of Device (1437); Self-Activation or Keying (1557); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that before a shoulder scope procedure, the hand control unit powered on by itself and was very hot.A backup device was available to use during the procedure.No patient injury or complications were reported.
 
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Brand Name
SVC REPL,MDU, HAND CNTRL, PWRMX
Type of Device
SAW, 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
james gonzales
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key5703201
MDR Text Key47995540
Report Number1643264-2016-00088
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,user f
Reporter Occupation Other
Type of Report Initial
Report Date 05/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72200616S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received05/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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