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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERV REPL ASCOPE A/C HD 30 DEG 4MM; ARTHROSCOPE
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SMITH & NEPHEW, INC. SERV REPL ASCOPE A/C HD 30 DEG 4MM; ARTHROSCOPE Back to Search Results
Model Number 72202087S
Device Problem Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
It was reported that the arthroscope's distal lens was found to be cracked.No case reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
H10, h3,h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found deep tip damage and a cracked negative lens.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.
 
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Brand Name
SERV REPL ASCOPE A/C HD 30 DEG 4MM
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key10796371
MDR Text Key219353156
Report Number3003604053-2020-00141
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 company representative,foreig
Type of Report Initial,Followup
Report Date 04/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number72202087S
Device Catalogue Number72202087S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2020
Date Manufacturer Received04/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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