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

Catalog Number	227204
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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.H11 additional narrative: 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, presumably biological 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, and a test footswitch was also 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 did not work as intended.However, 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 was sent to the manufacturer for further testing.An evaluation was performed with the following results: device was not received in its original packaging, only in a sterilization bag.There was residue on active tip and ceramic, just as saline crystals around the tip.The handle, cable and plug assembly was in good condition.The device failed both electrical hipot testing and functional ablation testing displaying an output shorted error most likely caused by an insufficient glue coverage between active tip and active suction assembly.The overall complaint was confirmed as the observed condition of vapr premiere 90 electrode -ea would have contributed to the complained issue.Based on the investigation findings, the potential cause for the observed condition is traced to manufacturing.The product issue has been addressed through depuy synthes 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 service and evaluation, it was determined that the vapr premiere 90 electrode device had foreign substance/debris/cleaning/sterilization.It was noted in the service order that the device was unable to ablate.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 Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24485206
• Report Number: 1221934-2026-00932
• Device Sequence Number: 10617524
• Product Code: GEI
• UDI-Device Identifier: 10886705009626
• UDI-Public: (01)10886705009626(10)U2502006
• 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

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: U2502006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/02/2026
• 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