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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR3 FOOTSWITCH *EA FOOT-SWITCH, ELECTRICAL

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DEPUY MITEK LLC US VAPR3 FOOTSWITCH *EA FOOT-SWITCH, ELECTRICAL Back to Search Results
Model Number 225023
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/18/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. 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. Udi: (b)(4).
 
Event Description
It was reported by the sales rep via phone that during an unknown procedure the vapr 3 footswitch was shorting out. Another device was used to complete the procedure. No patient consequences or surgical delay reported. It is unknown if the device is available to be returned for evaluation.
 
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Type of DeviceFOOT-SWITCH, ELECTRICAL
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10624246
MDR Text Key210073255
Report Number1221934-2020-02873
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041135
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number225023
Device Catalogue Number225023
Device Lot Number0904038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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