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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
Model Number 72202959
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/22/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the image went black and couldn't see out of it.No patient injury was reported.
 
Additional Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint that the image went black and couldn't see out of it.A visual inspection was performed and showed the scope to have deep scratched negative lens with distal tip and fiber damage.This 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 Key7276829
Report Number3003604053-2018-00027
Device Sequence Number1210575
Product Code HRX
UDI-Device Identifier00885554018783
UDI-Public(01)00885554018783
Combination Product (Y/N)N
Initial Reporter StateMA
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 Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 02/23/2018
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 Model Number72202959
Device Catalogue NumberED72202959S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2018
Initial Date Received by Manufacturer 01/22/2018
Supplement Date Received by Manufacturer02/20/2018
Initial Report FDA Received Date02/16/2018
Supplement Report FDA Received Date02/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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