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U.S. Department of Health and Human Services

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

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MEDOS INTERNATIONAL SàRL FOOT PEDAL(FMS VUE/NEXTRA) FOOT-SWITCH, ELECTRICAL Back to Search Results
Catalog Number 283573
Device Problem Intermittent Continuity (1121)
Patient Problem Not Applicable (3189)
Event Date 10/14/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Initial reporter phone number (b)(6). Udi:(b)(4). The serial number is number is unknown.
 
Event Description
It was reported by the affiliate via email that during a shoulder arthroscopy the foot pedal(fms vue/nextra) was trapped under the table, when the operation table was been set up. The table was unlocked, raised and than moved. It looks like the cable was run over and the pedal flaps were damaged. Also, the handpiece was constantly "on" only disconnecting the foot pedal from the pump console the handpiece will turn off. As per the surgeon the an alternate handpiece was used but the issued remained. An alternate foot pedal from a different pump had to be used to complete the procedure. No patient consequence was reported. However, there was a 2 minutes surgical delayed.
 
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Brand NameFOOT PEDAL(FMS VUE/NEXTRA)
Type of DeviceFOOT-SWITCH, ELECTRICAL
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle MA 02400
SZ 02400
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle MA CH-24 00
SZ CH-2400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key9312798
MDR Text Key207359416
Report Number1221934-2019-59493
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number283573
Device Lot NumberG46AY1855
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2020
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?
Type of Device Usage

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