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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTSWITCH,EP-1,PEDAL STYLE,; ARTHROSCOPE
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SMITH & NEPHEW, INC. FOOTSWITCH,EP-1,PEDAL STYLE,; ARTHROSCOPE Back to Search Results
Catalog Number 7205396
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/01/1901
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the reverse pedal was stuck causing continually run.No case involved.
 
Additional Manufacturer Narrative
The device was received for evaluation.There was a relationship found between the returned device and the reported incident.Product evaluation was performed and noted the reverse pedal¿s spring failed to recoil.The reverse pedal did not function.The complaint was confirmed and the root cause has been associated with a mechanical component failure.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
 
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Brand Name
FOOTSWITCH,EP-1,PEDAL STYLE,
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
MDR Report Key8349442
Report Number1643264-2019-00114
Device Sequence Number2287556
Product Code HRX
UDI-Device Identifier03596010251961
UDI-Public03596010251961
Combination Product (Y/N)N
Initial Reporter StateAL
Initial Reporter CountryUS
PMA/510(K) Number
K892062
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date (Section B) 04/04/2019
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
Operator of Device Health Professional
Device Catalogue Number7205396
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2019
Initial Date Received by Manufacturer 02/01/2019
Supplement Date Received by Manufacturer02/14/2019
04/03/2019
Initial Report FDA Received Date02/19/2019
Supplement Report FDA Received Date02/19/2019
04/04/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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