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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR FOOTSWITCH; HYSTEROSCOPE (AND ACCESSORIES)
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SMITH & NEPHEW, INC. TRUCLEAR FOOTSWITCH; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Catalog Number 7209820
Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)
Patient Problem No Patient Involvement (2645)
Event Date 05/15/2013
Event Type  malfunction  
Manufacturer Narrative
Product passed functional testing.All functions including window lock button perform as expected.No problem found.No further investigation is warranted at this time.(b)(4).
 
Event Description
It was reported that when you are pressing down on the foot pedal, it will pause the blade jumps, it will not window lock.There was no patient involvement reported.
 
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Brand Name
TRUCLEAR FOOTSWITCH
Type of Device
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
james gonzales
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key5029370
MDR Text Key24782346
Report Number1643264-2015-00137
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031787
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Report Date 05/28/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7209820
Device Lot NumberYG2006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2013
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/25/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2013
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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