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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
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/21/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy, the device was not working.The procedure was completed with a back up device with no patient injury reported.A delay greater than 30 minutes was reported.
 
Additional Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the device was not working.A visual inspection was performed and showed the scope to have distal tip and fiber damage, a bent outertube and a broken lens.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 Key9000694
Report Number3003604053-2019-00118
Device Sequence Number13544556
Product Code HRX
UDI-Device Identifier00885554018783
UDI-Public00885554018783
Combination Product (Y/N)N
Initial Reporter StateMS
Initial Reporter CountryUS
PMA/510(K) Number
K043395
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 09/30/2019
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 Number72202959
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2019
Initial Date Received by Manufacturer 08/21/2019
Supplement Date Received by Manufacturer09/30/2019
Initial Report FDA Received Date09/11/2019
Supplement Report FDA Received Date09/30/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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