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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 Problems Material Frayed (1262); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2022
Event Type  malfunction  
Event Description
It was reported by the sales rep that during a shoulder repair surgery on (b)(6) 2022, it was observed that the vapr3 footswitch device stopped working. According to the report, they tried moving the cord to get the device to work but it did not. Another like device was used to complete the procedure with delay of five minutes. There were no adverse patient consequences reported. No additional information was provided.
 
Manufacturer Narrative
Additional 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.
 
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Type of DeviceFOOT-SWITCH, ELECTRICAL
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key13445772
MDR Text Key287698505
Report Number1221934-2022-00408
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
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number225023
Device Catalogue Number225023
Device Lot Number1004026
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2010
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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