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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 11/09/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that was not possible to see through device, unable to get focus.There was not delay in case and back-up device was available.No patient injury was reported.
 
Additional Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for it was not possible to see through the device, unable to get focus.A visual inspection was performed and showed the scope to have distal tip damage, a cracked weld, and cracked internal lenses.This damage is caused by contact with another source.
 
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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 Key8121819
Report Number3003604053-2018-00184
Device Sequence Number1616205
Product Code HRX
UDI-Device Identifier00885554018783
UDI-Public00885554018783
Combination Product (Y/N)N
Initial Reporter StateAL
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) 12/21/2018
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 Catalogue Number72202959
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2018
Initial Date Received by Manufacturer 11/09/2018
Supplement Date Received by Manufacturer12/20/2018
Initial Report FDA Received Date12/01/2018
Supplement Report FDA Received Date12/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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