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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VAS, HD, AC, 4MM X 30 DEG; ARTHROSCOPE
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SMITH & NEPHEW, INC. VAS, HD, AC, 4MM X 30 DEG; ARTHROSCOPE Back to Search Results
Catalog Number 72202959
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/16/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy the scope was unable to focus, causing a complete loss of visualization.The procedure was completed with a backup device with no significant delay or patient injury reported.
 
Additional Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the scope would not focus.A visual inspection was performed and showed the scope to have deep distal tip damage, a broken sidearm and broken lenses.This damage is caused by contact with another source.No manufacturing related defects were observed.
 
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Brand Name
VAS, HD, AC, 4MM X 30 DEG
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key8594806
Report Number3003604053-2019-00059
Device Sequence Number2074730
Product Code HRX
UDI-Device Identifier00885554018783
UDI-Public00885554018783
Combination Product (Y/N)N
Initial Reporter CountryTC
PMA/510(K) Number
K043395
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/03/2019
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 Number72202959
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2019
Initial Date Received by Manufacturer 05/05/2019
Supplement Date Received by Manufacturer05/31/2019
Initial Report FDA Received Date05/09/2019
Supplement Report FDA Received Date06/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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