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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIDEOARTHROSCOPE HD 4MM X 30 DEG

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SMITH & NEPHEW, INC. VIDEOARTHROSCOPE HD 4MM X 30 DEG Back to Search Results
Catalog Number 72202961S
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2019
Event Type  malfunction  
Event Description
It was reported that during surgery, the device had an halo in the lens. No backup device was available to complete the procedure, and no delay or patient injuries were reported.
 
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Brand NameVIDEOARTHROSCOPE HD 4MM X 30 DEG
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 78735
5123913905
MDR Report Key8867938
MDR Text Key154570215
Report Number3003604053-2019-00086
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043395
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72202961S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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