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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FOOT PEDAL(FMS VUE/NEXTRA) FOOT-SWITCH, ELECTRICAL FOOT-SWITCH, ELECTRICAL

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MEDOS INTERNATIONAL SARL FOOT PEDAL(FMS VUE/NEXTRA) FOOT-SWITCH, ELECTRICAL FOOT-SWITCH, ELECTRICAL Back to Search Results
Model Number 283573
Device Problems Material Frayed (1262); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2021
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported by the sales rep that during an knee arthroscopy surgery on (b)(6) 2021, it was observed that the functionality on the foot pedal (fms vue/ nextra) device was inconsistent and its cord at the top of the device was coming out. Another like device was used to complete the procedure. There were no adverse patient consequences nor surgical delay reported. No additional information was provided.
 
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Brand NameFOOT PEDAL(FMS VUE/NEXTRA)
Type of DeviceFOOT-SWITCH, ELECTRICAL FOOT-SWITCH, ELECTRICAL
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ CH-2400
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle CH-24-00
SZ   CH-2400
6013142063
MDR Report Key12815047
MDR Text Key282116054
Report Number1221934-2021-03334
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283573
Device Catalogue Number283573
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Yes
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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