• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616S
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/12/2017
Event Type  malfunction  
Event Description
It was reported that the mdu cable became very hot during a shoulder scope procedure. A backup mdu was use to complete the procedure. No injuries or complications were noted as a result.
 
Manufacturer Narrative
Unit was powered on using the appropriate test equipment and it failed with "short circuit detected" error message and alarm. A kink was observed in the middle of the power cord. After troubleshooting, the cause of error was observed to be a defective power cord assembly. It was determined that the power cord has a shorted or open internal wire. Motor and hall board were tested and passed functional testing. The complaint was verified and the investigation has concluded that this unit has succumbed to physical damage to the power cord assembly. 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. Overheating is most likely associated with the short circuit in the power cord which can result in additional current delivery from the control unit and thus generate heat. No containment or corrective actions are recommended at this time. A review of the device history record was performed which confirmed no inconsistencies.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 w william cannon drive
austin, TX 78735
MDR Report Key6598785
MDR Text Key76385089
Report Number1643264-2017-00299
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010565105
UDI-Public(01)03596010565105
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,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-