MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR PREMIERE 90 ELECTRODE -EA; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	227204
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified surgery, the vapr premiere 90 electrode device did not absorb water.Another device was used to complete the surgery, so the aspirator was no problem.There were no adverse consequences to the patient.No additional information could be provided.
Additional 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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.
Additional 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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: the actual device was returned for evaluation.However, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once investigation has been completed, a follow-up report will be submitted accordingly.
Additional 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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: the product was returned to j&j medtech orthopaedics for evaluation.¿ visual inspection of the returned device found it was returned in original package.The tip showed signs of activation and had foreign matter.The tubbing had foreign matter residue.The tip, handle, shaft and plug did not show any signs of damage.A functional test was performed by activation of the device, the device was connected to a test generator, also a test footswitch was used, the default values were displayed correctly, no alert messages were displayed.The ablation function was activated using the foot pedal several times in its maximum power for one minute each test, and it worked as intended.The coagulation function was activated using the foot pedal several times in its maximum power for one minute each test, and it worked as intended.The device will be send to the manufacturer for further testing.The supplier performed an evaluation with the following results: device was received in its original packaging, the tip was used, there was residue around and within the active tip, saline residue was present on the tip front face.The handle had residue stains, there were black scratch marks on the ceramic tip.No other anomalies could be observed on the device.The device passed the electrical testing, but failed the flow rate test before and post activation.The customer reported that during the operation the device ¿could not suction.¿ the device passed all electrical tests with no issues.It also passed the activation tests but failed flow rate tests pre and post-activation.The complaint can be substantiated.The physical complaint device was returned for investigation.From investigation, the customer report that the electrode could not suction can be confirmed.The device was found to fail flow specifications due to a build-up of tissue debris at the distal end of the device.The complaint investigation shows the blockage experienced by the end user is confirmed and can be attributed to procedural tissue debris.No manufacturing defect was found with the returned device.The product instructions for use cautions not to allow the electrode to become covered in tissue debris.If this occurs, use a new electrode.The product instructions for use warns electrodes will wear from normal use, dependent on factors such as length of use, high tissue removal rate, prolonged use against bony surfaces, prolonged use in saline, high power settings, and use with minimal suction or fluid management.Periodically assess electrode tip for wear and proper operation.Replace the electrode if excessive wear is noted.The overall complaint was confirmed as the observed condition of vapr premiere 90 electrode -ea would have contributed to the complained issue.A manufacturing record evaluation was performed for the finished device u2410005, and no non-conformances were identified.¿ based on the investigation findings, the potential cause for the observed condition is traced to the procedural variables, such handling of the device or normal product interaction during procedure.As per instructions for use, do not allow the electrode to become covered in tissue debris.If this occurs, use a new electrode.Additionally, electrodes will wear from normal use, depending on factors such as length of use, high tissue removal rate, prolonged use against bony surfaces, prolonged use in saline, high power settings, and use with minimal suction or fluid management.Periodically assess electrode tip for wear and proper operation.Replace the electrode if excessive wear is noted.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: VAPR PREMIERE 90 ELECTRODE -EA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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 Key: 23004763
• Report Number: 1221934-2025-03388
• Device Sequence Number: 10509032
• Product Code: GEI
• UDI-Device Identifier: 10886705009626
• UDI-Public: (01)10886705009626(10)U2410005(17)271014
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 227204
• Device Lot Number: U2410005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/10/2025; 10/21/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 09/15/2025; 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown