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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4KO VIDEOARTHROSCOPE AC 4X30X160MM
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SMITH & NEPHEW, INC. 4KO VIDEOARTHROSCOPE AC 4X30X160MM Back to Search Results
Model Number 72205149
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that, during use, the scope lens was cracked externally.The procedure was successfully completed without delay using a smith and nephew back up device.No patient injury or other complications were reported.
 
Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found distal tip and fiber damage, a cracked distal lens, and moisture.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
4KO VIDEOARTHROSCOPE AC 4X30X160MM
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key11845400
MDR Text Key251440958
Report Number3003604053-2021-00202
Device Sequence Number1
Product Code HRX
UDI-Device Identifier00885556735954
UDI-Public00885556735954
Combination Product (y/n)N
PMA/PMN Number
K201349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number72205149
Device Catalogue Number72205149
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2021
Date Manufacturer Received06/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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