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	06/09/2025
Type of Reportable Event	Malfunction
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 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.H11 additional narrative: 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 or Problem Description
It was reported that during a rotator cuff repair surgery, it was observed that the vapr premiere 90 electrode device suction function did not work properly.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was 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 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.H11 additional narrative: the complaint device was not returned to j&j medtech orthopaedics, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (u2412007), and no non-conformance was identified.Based on the current available information, we cannot determine a root cause for the reported failure.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and 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.
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 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.H11 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent 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 medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: investigation summary: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found it was not returned in original package.The tip showed signs of activation and had foreign matter.The tubing 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 (vapr vue, ablate power 240 and coagulate power 120), no alert messages were displayed.The ablation function was activated using the foot pedal several times in its maximum power (maximum ablate power 260) 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 (maximum coagulate power 160) 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 not received in its original packaging, only on the carton, the tip was used, there was tissue residue around and within the active tip, the suction hole was partially blocked.There was residue within suction tube.No other anomalies could be observed on the device.The device passed both the electrical and functional testing.The complaint stated, ¿suction function didn¿t work properly¿.Initial inspection showed a partially blocked suction hole.The device passed all electrical and functional tests, including the flow rate test, while the suction hole was partially blocked on receipt, the flow rate was still found within manufacturer¿s specifications.The complaint of the suction function not working properly cannot be substantiated.The overall complaint was not confirmed as the observed condition of vapr premiere 90 electrode -ea would have not contributed to the complained issue.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 (ifu); 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 depuy synthes 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.Device history review: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance was identified.

• 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
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 22192906
• Report Number: 1221934-2025-02178
• Device Sequence Number: 8628292
• Product Code: GEI
• UDI-Device Identifier: 10886705009626
• UDI-Public: (01)10886705009626(10)U2412007(17)271216
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 06/12/2025

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: U2412007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 10/29/2025; 12/11/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 06/30/2025; 10/30/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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