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

Catalog Number	227204
Medical Device Problem Codes	Use of Device Problem (1670); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
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: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed that the external appearance of the device is in a normal used condition.To test its functionality the device was connected to a test generator, coagulation and ablation function worked as intended.The device was sent to the supplier for further evaluation.The supplier performed an evaluation with the following results: device tip, handle, cable and plug are in used condition.Other observations; kink in the suction tube and saline residue in the suction tube.The device passed all electrical checks, however it failed functional flow rate tests pre and post activation.From our investigation we were able to confirm the customer report that the electrode suction was jammed with the returned device.The device was found to fail flow specifications due to a build-up of tissue debris at the distal end of the device which could not be cleared during testing.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 ifu cautions not to allow the electrode to become covered in tissue debris.If this occurs, use a new electrode.The product ifu 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.Based on a review of the complaint investigation outcome no containment action related to the individual complaint is required.The overall complaint was confirmed as the observed condition of the vapr premiere 90 electrode -ea would have contributed to the complained device issue.¿ based on the investigation findings, the potential cause can be traced to user.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.¿ a manufacturing record evaluation was performed for the finished device and no non-conformances were identified.
Event or Problem Description
It was reported that during a shoulder repair surgical procedure, the vapr premiere 90 electrode -ea device was jammed and did not work.During in-house engineering evaluation, it was determined that the device suction failed.There was patient involvement.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• 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: 21666370
• Report Number: 1221934-2025-01068
• Device Sequence Number: 7756256
• Product Code: GEI
• UDI-Device Identifier: 10886705009626
• UDI-Public: (01)10886705009626(10)U2405068(17)270430
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

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: U2405068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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