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

Catalog Number	227204
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.E1: the reporter¿s complete facility address was not provided.
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair procedure that the vapr premiere 90 electrode device generated sparks.Another device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.All available information has been disclosed.
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: d9, h3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that it was received in its original package.The tip had signs of activation, and the device had foreign matter, presumably biological matter.The tip, handle, shaft 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 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 worked as intended.The coagulation function was activated using the foot pedal several times in its maximum power (maximum coagulate power) for one minute each test, and it worked as intended.The overall complaint was not confirmed as the observed condition of the vapr premiere 90 electrode -ea would have not contributed to the complained device issue.Based on the findings, the investigation could not draw any conclusions and no potential cause about the reported event can be established due to the insufficient evidence provided.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 depuy synthes 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.Device history review: manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.
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: d4.Expiration date: added.Corrected data: d4.Primary udi number.The actual device was returned for evaluation.However, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once the investigation has been completed, a follow-up report will be submitted accordingly.

• Brand Name: VAPR
• 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: 24705146
• Report Number: 1221934-2026-01271
• Device Sequence Number: 13273322
• Product Code: GEI
• UDI-Device Identifier: 10886705009626
• UDI-Public: (01)10886705009626(10)U2505003(17)280506
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: U2505003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 04/22/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/22/2026; 04/23/2026
• 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