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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
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2019
Event Type  malfunction  
Event 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.
 
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
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key8594806
MDR Text Key144690227
Report Number3003604053-2019-00059
Device Sequence Number1
Product Code HRX
UDI-Device Identifier00885554018783
UDI-Public00885554018783
Combination Product (y/n)N
PMA/PMN Number
K043395
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Catalogue Number72202959
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2019
Initial Date Manufacturer Received 05/05/2019
Initial Date FDA Received05/09/2019
Supplement Dates Manufacturer Received05/31/2019
Supplement Dates FDA Received06/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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