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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 Consequences Or Impact To Patient (2199)
Event Date 11/08/2016
Event Type  malfunction  
Event Description
It was reported that the device is not working.No patient injury or complications were reported.
 
Manufacturer Narrative
Reassessment of this submission has led to the determination that this is not a reportable event.Please disregard the initial report.
 
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Brand Name
VIDEOARTHROSCOPE, HD, 4MM X 30 DEG
Type of Device
ARTHROSCOPE
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
james gonzales
7000 w. william cannon drive
austin, TX 78735
5123585706
MDR Report Key6145769
MDR Text Key61700141
Report Number3003604053-2016-00118
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,health
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 11/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number72202961S
Device Lot NumberCCG1073291
Other Device ID NumberCCG1073291
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2016
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 Reuse
Patient Sequence Number1
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