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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR VUE GENERATOR; ELECTROSURGICAL SYSTEM GENERATOR
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DEPUY MITEK LLC US VAPR VUE GENERATOR; ELECTROSURGICAL SYSTEM GENERATOR Back to Search Results
Model Number 225024
Device Problem Device Remains Activated (1525)
Patient Problems Burn(s) (1757); Not Applicable (3189)
Event Date 10/16/2020
Event Type  Injury  
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.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary : the complaint device was received at the medifix service and evaluated.It was reported that during a shoulder arthroscopy case using the vapr vue generator 225024 & footpedal 225023 with vapr coolpulse 90 wand 225028 lot: u2001149.I was contacted via email by nursing staff who state the vapr wand "activated itself" & caused a burn to the patient.At the time of reporting no other information regarding the incident was available.I have contacted the nursing staff directly to request further detailed information regarding the incident / injury & am currently awaiting a response.Per service manual operational and diagnostic, the reported failure was not confirmed.During evaluation, the unit passed the electrical test and the fault was not able to be reproduced on the generator.Also, it was found signs of multiple repairs to wired footswitch.Finally, the unit passed all functional tests and is fully operational.The photo provided by the customer only showed the serial number information of the device.We cannot discern a root cause for the reported failure.The possible root cause for the nicks found could be related to fair wear and tear.However, it cannot be conclusively affirmed.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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.
 
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Brand Name
VAPR VUE GENERATOR
Type of Device
ELECTROSURGICAL SYSTEM GENERATOR
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key10813773
MDR Text Key215516174
Report Number1221934-2020-03380
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10886705009121
UDI-Public10886705009121
Combination Product (y/n)N
PMA/PMN Number
K113545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Model Number225024
Device Catalogue Number225024
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Date Manufacturer Received01/02/2021
Patient Sequence Number1
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