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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIDEOARTHORSCOPE HD 4MM X 70 DEG ARTHROSCOPE

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SMITH & NEPHEW, INC. VIDEOARTHORSCOPE HD 4MM X 70 DEG ARTHROSCOPE Back to Search Results
Model Number 72202962S
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/18/2020
Event Type  malfunction  
Manufacturer Narrative
Device is currently under investigation by the manufacturing registered site.
 
Event Description
It was reported that during hip arthroscopy procedure, the scope was scratched. No significant delay and a back up was available to complete the procedure. No other complications were reported. Preliminary results of investigation have concluded that the scope had a cracked distal lens which makes it a reportable event. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameVIDEOARTHORSCOPE HD 4MM X 70 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, TX 78735
5123913905
MDR Report Key10694675
MDR Text Key211888833
Report Number3003604053-2020-00128
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 company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72202962S
Device Catalogue Number72202962S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2020
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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