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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIDEOARTHORSCOPE HD 4MM X 70 DEG; ARTHROSCOPE
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SMITH & NEPHEW, INC. VIDEOARTHORSCOPE HD 4MM X 70 DEG; ARTHROSCOPE Back to Search Results
Catalog Number 72202962S
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/13/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that scope was shattered at the tip.No patient injuries or delay were reported.Back-up device was available to complete the surgery.It is unknown if the device broke off inside the patient's anatomy.
 
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
VIDEOARTHORSCOPE HD 4MM X 70 DEG
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key8391843
Report Number3003604053-2019-00026
Device Sequence Number2029648
Product Code HRX
UDI-Device Identifier00885554024210
UDI-Public00885554024210
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,health
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/17/2019
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 Number72202962S
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/21/2019
Supplement Date Received by Manufacturer04/16/2019
Initial Report FDA Received Date03/05/2019
Supplement Report FDA Received Date04/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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