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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO VIDEOARTHROSCOPE REV POST HD 4MM X70
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SMITH & NEPHEW, INC. MTO VIDEOARTHROSCOPE REV POST HD 4MM X70 Back to Search Results
Catalog Number 72202964S
Medical Device Problem Code Optical Obstruction (3002)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/13/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during hip scope surgery, the device had an halo around the outer edge.It is unknown whether there was a back up available and there was a delay greater than 30 minutes.No patient injuries were reported.
 
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.
 
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Brand Name
MTO VIDEOARTHROSCOPE REV POST HD 4MM X70
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key8783631
Report Number3003604053-2019-00074
Device Sequence Number11301469
Product Code HRX
UDI-Device Identifier00885554024234
UDI-Public00885554024234
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K043395
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number72202964S
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/14/2019
Supplement Date Received by Manufacturer07/26/2019
Initial Report FDA Received Date07/12/2019
Supplement Report FDA Received Date07/30/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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