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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 Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2018
Event Type  malfunction  
Event Description
It was reported that during the shoulder surgery, the scope was cracked.The procedure was successfully completed with more than 30 minutes delay and a back-up device was available.No patient injury or other complications were reported.
 
Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the scope was cracked.A visual inspection was performed and showed the scope to have distal tip damage and internal cracked lenses.This damage is caused by contact with another source.No manufacturing related defects were observed.No further investigation is required.
 
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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 Key8245400
MDR Text Key133186281
Report Number3003604053-2019-00003
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 02/13/2019
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 Manufacturer12/28/2018
Initial Date Manufacturer Received 12/21/2018
Initial Date FDA Received01/14/2019
Supplement Dates Manufacturer Received02/12/2019
Supplement Dates FDA Received02/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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