SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/1901 |
Event Type
malfunction
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Event Description
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It was reported that, during a shoulder repair procedure, the shaver handpiece got hot during a surgery.A back-up device was available to complete the procedure.However, it is unknown if a delay happened in the procedure.Moreover, no patient injuries were reported.
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Event Description
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It was reported that during a shoulder repair procedure, the shaver handpiece got hot.Backup device was available to complete the procedure.There was no significant delay in the procedure.Moreover, no patient injuries were reported.
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Manufacturer Narrative
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The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of overheating could not be reproduced.Product did not overheat during functional testing but did fail for handpiece error.Mdu had a stuck button but did not overheat.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.
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Search Alerts/Recalls
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