• 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
Catalog Number 225023
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Not Applicable (3189)
Event Date 08/26/2019
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. Udi: (b)(4).
 
Event Description
It was reported by the sales rep via email that during a shoulder scope procedure the vapr iii foot pedal did not operate normally. The blue pedal would not function when pressed. The procedure was completed with another pedal. There was a one minute surgical delay to switch the pedals and no patient harm.
 
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 Key9106443
MDR Text Key196397432
Report Number1221934-2019-58463
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
Report Date 08/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number225023
Device Lot Number0407159
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-