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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 Date 05/14/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that during a knee scope, the scope lens was cracked externally. The procedure was successfully completed without delay using a back-up device. No patient injury or other complications were reported.
 
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Brand Name4KO VIDEOARTHROSCOPE AC 4X30X160MM
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11964924
MDR Text Key255139782
Report Number3003604053-2021-00219
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72205149
Device Catalogue Number72205149
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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