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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERV REPL, A'SCOPE, A/C, HD, 30°, 4MM; ARTHROSCOPE
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SMITH & NEPHEW, INC. SERV REPL, A'SCOPE, A/C, HD, 30°, 4MM; ARTHROSCOPE Back to Search Results
Catalog Number 72202087S
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/1901
Event Type  malfunction  
Event Description
It was reported that, during an unspecified orthopaedic arthroscopy, the image could not be seen through the arthroscope.A back-up device was available to complete the procedure in the scheduled time.The patient was not harmed.
 
Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for there was no image.A visual inspection was performed and showed the scope to have deep distal tip damage and broken lenses.This damage is caused by contact with another source.No manufacturing related defects were observed.
 
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Brand Name
SERV REPL, A'SCOPE, A/C, HD, 30°, 4MM
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key8952963
MDR Text Key156336428
Report Number3003604053-2019-00108
Device Sequence Number1
Product Code HRX
UDI-Device Identifier03596010644534
UDI-Public03596010644534
Combination Product (y/n)N
PMA/PMN Number
K962075
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 09/17/2019
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 Number72202087S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2019
Initial Date Manufacturer Received 08/12/2019
Initial Date FDA Received09/01/2019
Supplement Dates Manufacturer Received09/16/2019
Supplement Dates FDA Received09/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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