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); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2025
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: e1: the initial reporter facility name was not provided.H4: the device manufacture date is currently unavailable.The products were returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found it was returned in its original package.The tip and suction tube had foreign matter.The tip, handle, shaft, tubbing 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: the device was received in its original packaging, the tip was in used condition, residue was found around the active tip, there was rust on the tip front face.There was small residue stains on the handle.The device failed the return continuity test but passed the activation tests when tested for ten seconds, showing intermittent continuity.The device was opened, and the return clip was not fully attached to the return shaft.The clip was free to move which allowed for the intermittent continuity, to pass the activation but not continuity.The complaint can be substantiated.From investigation were able to confirm a fault.During the atl uk product evaluation the device was found to fail electrical return continuity testing.Further investigation was performed: with the electrode handle taken apart a poor connection of the return clip to the return shaft was observed due to an incorrect orientation of the return clip.The defect seen can be attributed to a manufacturing fault (human error) caused by an incorrect orientation of the return clip figment onto the return tube, the return clip should be clipped on the return tube securely as detailed in the product assembly aid 588090-ak.Based on a review of the investigation findings, product ra and the defect being an isolated case, no containment or correction action related to the individual complaint is recommended.Through the atl uk defect awareness programme, the information regarding this customer complaint will be shared with the manufacturing team.The overall complaint was confirmed as the observed condition of vapr tripolar 90 suction elect would have contributed to the complained issue.Based on the investigation findings, the potential cause for the observed condition is traced to manufacturing error.The product issue has been addressed through supplier quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Event or Problem Description
It was reported that during an anterior cruciate ligament repair surgery, it was observed that after connection of the vapr premiere 90 electrode device with the generator, it did not function at all and the screen did not show any alert code.During in-house engineering evaluation, it was determined that the device had intermittent operation.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be 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
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 23423013
• Report Number: 1221934-2025-04122
• Device Sequence Number: 9536400
• Product Code: GEI
• UDI-Device Identifier: 10886705009626
• UDI-Public: (01)10886705009626(10)U2408006(17)270812
• 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
• Report Date (Section B): 10/30/2025

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: 227204
• Device Lot Number: U2408006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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