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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
Model Number 72202961S
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2020
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that the scope was cracked. No case involved. Therefore, there was no patient involved. Results of investigation have shown 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 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, TX 78735
5123913905
MDR Report Key11479045
MDR Text Key244867426
Report Number3003604053-2021-00087
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K043395
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72202961S
Device Catalogue Number72202961S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2021
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?
Type of Device Usage Unkown

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