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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 Intermittent Continuity (1121)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/22/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (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. Udi: (b)(4).
 
Event Description
It was reported by the sales rep via phone that during a rotator cuff repair the vapr 3 footswitch stopped working. Another device was used to complete the procedure. No patient consequences or surgical delay reported. 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 Key10645539
MDR Text Key210440746
Report Number1221934-2020-02906
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,Followup,Followup
Report Date 09/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number225023
Device Catalogue Number225023
Device Lot Number1405240
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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