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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 Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/13/2016
Event Type  malfunction  
Event Description
It was reported that the scope was completely blacked out.
 
Manufacturer Narrative
Examination was not possible, as the device was not returned. The investigation was limited to the information provided. The investigation could not draw any conclusions about the reported event with the clinical details provided. A review of the device history record was performed which confirmed no inconsistencies. No further investigation is warranted at this time.
 
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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
jim gonzales
7000 w. william cannon
austin, TX 78735
5123585706
MDR Report Key6066342
MDR Text Key58778667
Report Number3003604053-2016-00104
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72202961S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2016
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

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