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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 Corroded (1131); Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: udi: (b)(4). Investigation summary: the device was received at the service center. It was reported that the fault code 600 ref 20 is occurring frequently. Per service reports, this complaint can be confirmed. A preliminary visual evaluation was performed and rust on the foot pedal cut side was observed. However, the device was found to be irreparable and was returned to the customer without repair, hence is unavailable for further evaluation. The faulty parts was identified as the root cause for the device failure during the service evaluation. A manufacturing record evaluation was performed for the finished device lot number (1805051), and no non-conformance was identified. At this point in time, no corrective action is required, and no further action is warranted. However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. Device history lot: an mre review was performed and results obtained as below: anomalies or discrepancies (non-conformance): none.
 
Event Description
It was reported from the affiliate that the vapr3 footswitch device stuck (fault code 600 ref 20) was occurring frequently even after re-starting. When restarting, the evaporation (yellow) foot switch was stepped on, but it moved while blinking. The state continued, and when the hemostatic (blue) foot switch was stepped on, the hemostatic mode was entered only then. However, it remained in transpiration mode without stepping on any footswitch. During an in-house engineering evaluation, it was determined that the device had rust on the foot pedal on the cut side was observed. It was not reported if the device was used in surgery, or if there was patient involvement. It was not reported if there were any delays in the procedure or whether a like device was available for use. The exact date of this event was unknown but was noted to have occurred in 2021. There were no adverse patient consequences reported. No additional information was provided.
 
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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
6103142063
MDR Report Key12370777
MDR Text Key268248531
Report Number1221934-2021-02562
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 08/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number225023
Device Catalogue Number225023
Device Lot Number1805051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2021
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 Unkown

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