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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 Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that, during an acl reconstruction, the arthroscopic image was totally unusable as the lens was scratched.The operation was concluded with a competitor device.The surgery was delayed for less than 30 min.The patient was not injured.
 
Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the lens was scratched.A visual inspection was performed and showed the scope to have distal tip and fiber damage and deep scratches on the negative lens.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 Key8915238
MDR Text Key155047103
Report Number3003604053-2019-00094
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 foreign,health professional,o
Type of Report Initial,Followup
Report Date 09/19/2019
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 Number72202087
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2019
Initial Date Manufacturer Received 08/07/2019
Initial Date FDA Received08/21/2019
Supplement Dates Manufacturer Received09/18/2019
Supplement Dates FDA Received09/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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