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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR S90 ELECTRODE 4.0MM, 90° SUCTION W/INTEGRATED HANDPIECE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
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DEPUY MITEK LLC US VAPR S90 ELECTRODE 4.0MM, 90° SUCTION W/INTEGRATED HANDPIECE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE Back to Search Results
Model Number 225370
Device Problems Electrical /Electronic Property Problem (1198); Environmental Particulates (2930)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2022
Event Type  malfunction  
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).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.
 
Event Description
This is report 5 of 5 for (b)(4).It was reported by a healthcare professional in france that during an rotator cuff repair procedure of the right shoulder, it was observed that there were smoke, sparks and smell of burning while using two unknown generator devices with three vapr s90 electrode 4.0mm, 90° suction w/integrated handpiece devices.There were no adverse patient consequences reported.No additional information was provided.
 
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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 not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.A manufacturing record evaluation was performed for the finished device lot number (u2106101), and no non-conformance was identified.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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 S90 ELECTRODE 4.0MM, 90° SUCTION W/INTEGRATED HANDPIECE
Type of Device
ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kate karberg
325 paramount drive
raynham, MA 02767
3035526892
MDR Report Key15668703
MDR Text Key306792258
Report Number1221934-2022-03277
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10886705009398
UDI-Public10886705009398
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K120095
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number225370
Device Catalogue Number225370
Device Lot NumberU2106101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
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