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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 No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/05/2019
Event Type  malfunction  
Event Description
It was reported that during a shoulder arthroscopy procedure the lens fell apart during use so there was not anyway there could be an image maintained during the surgical procedure, the image was lost.A backup device was used to complete the surgery.No delay or patient injury reported.
 
Manufacturer Narrative
An evaluation was performed by the supplier and could not confirm the customer complaint for the lens fell apart.A visual inspection was performed and showed the scope to have deep distal tip damage and a broken sidearm.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 Key8939884
MDR Text Key156472321
Report Number3003604053-2019-00103
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 company representative,user f
Type of Report Initial,Followup
Report Date 09/12/2019
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 Number72202959S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2019
Initial Date Manufacturer Received 08/06/2019
Initial Date FDA Received08/28/2019
Supplement Dates Manufacturer Received09/11/2019
Supplement Dates FDA Received09/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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