SMITH & NEPHEW, INC. SERV REPL HD COUPLER 19.5MM; INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE
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Catalog Number 72201635S |
Device Problem
Misfocusing (1401)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/23/2019 |
Event Type
malfunction
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Event Description
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It was reported that during a shoulder procedure, the device would not stay focus secure and lose focus.There was a delay of more than 30 minutes.A backup device was used to complete the procedure with no patient injury reported.
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Manufacturer Narrative
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An evaluation was performed by smith and nephew and could not confirm the customer complaint for the pieces won't stay together and loose focus.A visual inspection was performed and showed no components of the coupler were loose.The coupler is scratched , dented, and severely faded.Functional inspection was performed and showed when the coupler was attached to the camera system it provided a clear sharp image.This device was shipped to the customer on (b)(6) 2016.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defected were observed.
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Search Alerts/Recalls
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