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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 Loss of or Failure to Bond (1068)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
As reported by clinical engineering the coag is not firing and the cuts is firing very little.No other information was available.
 
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 service center and evaluated.Per service manual operational and diagnostic, this complaint can be confirmed.It was noticed during evaluation that the top and base plates had big dents on the left side.The facia had multiple scratches.Further, invalid instrument error code was observed, and the dust cover was found to be missing.The top plate, base plate, facia moulding, facia badge, 8-way socket assembly and dust cover were replaced to resolve the issues.Graphic panels and keypad membrane were replaced for re-skinning purpose.After repair, the device was found to be working according to the specifications.As per the analysis by the service center, the dents on the top and base plates were most probably caused by a drop/fall from the customer.User mishandling and/or lack of maintenance can be the most probable root causes of the missing dust cover and observed scratches on the facia.The defective 8-way assembly would have caused the device to display invalid instrument error code.The damaged, missing, and defective components are identified as the root causes of the reported problem.A manufacturing record evaluation was performed for the finished device serial number ((b)(6)), 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.
 
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: correction: h6: method codes: it was inadvertetnly missed on the initial report that a manufacturing record evaluation was performed for the finished device [ad1520906] number, and no non-conformances were identified.Additional information: d10, 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.
 
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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 Key10489751
MDR Text Key206379824
Report Number1221934-2020-02389
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 health professional,other
Type of Report Initial,Followup,Followup
Report Date 08/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
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 Manufacturer08/20/2020
Initial Date Manufacturer Received 08/14/2020
Initial Date FDA Received09/03/2020
Supplement Dates Manufacturer Received09/16/2020
09/30/2020
Supplement Dates FDA Received09/17/2020
09/30/2020
Patient Sequence Number1
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