MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR PREMIERE50 ELECTRODE -EA; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	227504
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	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during service and evaluation, it was determined that the vapr premiere50 electrode device had visual: foreign substance/debris/cleaning/sterilization.It was noted in the service order that during hip arthroscopy surgery, the device would not cut.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 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 that it was not returned in its original package.The tip showed signs of activation.The handle, shaft, tubbing and plug did not show any signs of damage.No other anomalies were noted.A functional test was performed by activation of the device.The default values were displayed correctly and no alert messages were displayed.The ablation function was activated several times in its maximum power, and it did not work as intended.Under coagulation function, the electrode was activated several times in its maximum power, and the coagulation function did not work as expected.Thus, the device did not function as intended in both modes using the footswitch.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 bag.There was some residue on the ceramic and eschar built up on the active tip.Electrode failed both electrical and functional tests, particularly failing high potential safety test (hipot active - return) and foot-switch activation with output short error message displayed on the generator (ablate and coagulation output short errors).There was no evidence of misuse on the device as presented.Due to the results of the checks, the device was further investigated.During investigation, evidence of saline ingress was found inside when the the upper handle was removed.As a result of this, a water pressure test from the suction tube to the tip was conducted which found that saline was leaking into the handle from the exit of the outer shaft inside the handle.This finding can be confirmed as a manufacturing fault for tip assembly adhesive application, where the potential effect of failure is that the suction tube is not retained because of the operator applied insufficient adhesive in the process allowing for movement of the suction tube, allowing saline to leak into the handle.The overall complaint was confirmed as the observed condition of vapr premiere50 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.Device history review: there was no non-conformance regarding this lot.

• Brand Name: VAPR PREMIERE50 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: 24524498
• Report Number: 1221934-2026-00969
• Device Sequence Number: 8522391
• Product Code: GEI
• UDI-Device Identifier: 10886705009923
• UDI-Public: (01)10886705009923(10)U2411002(17)271111
• 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

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: 227504
• Device Lot Number: U2411002
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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