• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY MITEK LLC US VAPR3 FOOTSWITCH *EA FOOT-SWITCH, ELECTRICAL Back to Search Results
Model Number 225023
Device Problem Device Remains Activated (1525)
Patient Problems Burn(s) (1757); Not Applicable (3189)
Event Date 10/16/2020
Event Type  malfunction  
Manufacturer Narrative
(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. (b)(4).
 
Event Description
It was reported by the sales rep via complaint submission tool that during a shoulder acromioplasty while using the vapr vue generator and the vapr3 footswitch, the vapr coolpulse 90 electrode activated itself causing a burn in the patient. At the time of reporting no other information regarding the incident was available. The electrode was discarded by the staff.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10813893
MDR Text Key215483674
Report Number1221934-2020-03381
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K041135
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number225023
Device Catalogue Number225023
Device Lot Number1307086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/02/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-