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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 72202959S
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2019
Event Type  malfunction  
Event Description
It was reported that during an arthroscopy, the device went blank.There was not an available backup device.Neither delay or patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
H3, h6: the device, which was used in a procedure, was returned for evaluation.The evaluation was performed by the supplier and could confirm the customer complaint for the image was blank.A visual inspection was performed and showed the scope to have distal tip damage, a dented outertube and broken lenses.This damage is caused by contact with another source.A review of the device history records and of the complaint history listing concluded that there were no indications to suggest that the product did not meet manufacturing specifications.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 Key9372662
MDR Text Key183483713
Report Number3003604053-2019-00136
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K043395
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 01/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72202959S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2019
Date Manufacturer Received12/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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