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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. A'SCOPE, A'CLAVE, HD, 4MM X 30°; ARTHROSCOPE
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SMITH & NEPHEW, INC. A'SCOPE, A'CLAVE, HD, 4MM X 30°; ARTHROSCOPE Back to Search Results
Catalog Number 72202087
Device Problem Crack (1135)
Patient Problem No Code Available (3191)
Event Date 06/08/2018
Event Type  malfunction  
Event Description
It was reported that device appeared to be cracked.There was a delay of greater than 30 minutes and the patient was already under anaesthetic but surgery had to be cancelled due to no back up device.No patient injury was reported.
 
Manufacturer Narrative
Serial number added.
 
Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the device appeared to have a black image.A visual inspection was performed and showed the scope to have a dented outertube with internal cracked lenses.This damage is caused by contact with another source.No manufacturing related defects were observed.
 
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Brand Name
A'SCOPE, A'CLAVE, HD, 4MM X 30°
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key7608465
MDR Text Key111849457
Report Number3003604053-2018-00093
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K962075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other,use
Type of Report Initial,Followup,Followup
Report Date 08/21/2018
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 Number72202087
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2018
Initial Date Manufacturer Received 06/11/2018
Initial Date FDA Received06/17/2018
Supplement Dates Manufacturer Received06/18/2018
08/17/2018
Supplement Dates FDA Received06/18/2018
08/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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