MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR P50 W/ HAND CONTROLS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	228504
Medical Device Problem Codes	Device Remains Activated (1525); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
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 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.
Event or Problem Description
It was reported that during an unknown surgery, it was observed that multiple button of the vapr p50 w/ hand controls device were pressed and the rf wand was still working and could not close.Another device was used to complete the surgery.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 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.H11 additional narrative: device history review: a manufacturing record evaluation was performed for the finished device u2409001, and no non-conformances were identified.Investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found signs of usage on the overall device surface.No other anomalies were noted.A functional test was performed for the device using saline water.Test revealed that only the coagulation function could be activated as intended.As intermittence was identified while pressing the ablation button, the device will be sent to the supplier for further investigation.The supplier performed an evaluation with the following results: the device was received in the original packing; the tip was in used condition with crystalized saline residue.Some residue was around the manifold.Procedural residue was visible in the suction tube; no other anomalies could be observed on the device.The device passed the electrical testing and functional testing.Further investigation was performed; multiple presses of the hand switch buttons did not cause intermittent activation.The customer stated that ¿button issue.It was reported that during the operation, multiple button presses, the rf wand is still working and cannot close¿.The testing established that the hand and foot switching were working correctly as intended.This complaint cannot be substantiated with the device passing the electrical and functional tests with no issues encountered.No further investigation is required as the complaint device reported was found to meet manufacturer¿s specifications, and as a result the root cause of the reported complaint could not be determined in this instance.The overall complaint was no confirmed as the observed condition of vapr p50 w/ hand controls 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.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 P50 W/ HAND CONTROLS
• 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: 22356844
• Report Number: 1221934-2025-02388
• Device Sequence Number: 8759482
• Product Code: GEI
• UDI-Device Identifier: 10886705020942
• UDI-Public: (01)10886705020942(10)U2409001(17)270902
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K122425
• 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
• Report Date (Section B): 06/30/2025

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: 228504
• Device Lot Number: U2409001
• 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: 06/15/2025
• Supplement Date Received by Manufacturer: 07/07/2025; 08/28/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/08/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown