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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The reported device, used in treatment, was received for evaluation. There was a relationship found between the returned device and the reported incident. Visual inspection found deep damage to the distal tip and fiber and a cracked distal lens. The complaint was confirmed. Factors that could have contributed to the reported event include an impact event inconsistent with normal use. No containment or corrective actions are recommended at this time.
 
Event Description
It was reported that during a knee arthroscopy surgery the scope image was occluded. No patient injuries or significant delay reported. Smith and nephew back-up device was available to complete the surgery. Results of investigation have concluded that this unit have 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 Key11392826
MDR Text Key234017430
Report Number3003604053-2021-00064
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
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
Report Date 03/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2021
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 Manufacturer11/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
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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