MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR S90 W/ HAND CONTROLS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	228370
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy surgical procedure it was observed that the vapr s90 w/ hand controls electrode device generated sparks.It was reported that the device was not used on the patient.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 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.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.
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.H11 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.
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 of the returned device found one portion of the manifold charred and the electrode not centered at its intended position.No other anomalies were noted.A functional test was unable to be performed due to the post-manufacturing damage.Device will be sent to the supplier for further investigation.The manufacturer inspection revealed the following conditions on the device surface: the original packaging was not returned for evaluation; the tip components were used and had some visible damage on the lower manifold; there was visible tissue within the active tip; the handle assembly, cable & plug assembly were in good and used condition and no misuse patterns were observed on them; and there were minor scuffs on the cable.During testing, the manufacturer was able to confirm a fault with the device, as the visible damage to the lower manifold and activation tests confirmed that arcs (sparks) were visible during ablate function tests.The complaint device failed both electrical (hipot active: return) and functional (output short displayed) testing.Based on the evidence of the damaged section of the lower manifold seen for the returned electrode, the likely cause of this failure is shorting at distal tip.The failure mode seen is consistent with previous s90 handswitching/one piece lps electrodes which exhibit similar failure modes including output shorting, manifold melting, sparking and arcing during a surgical procedure and have been further investigated through a supplier capa.To eliminate recurrence of this failure mode a design change has been required.The overall complaint was confirmed as the observed condition of the vapr s90 w/ hand controls would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received and attributed to a design error.This product issue will be addressed through atl uk quality system.Furthermore, for the scuffs on cable and the foreign matter observed on the active tip, potential cause can be traced to handling/care of the device or procedural variables.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: a manufacturing record evaluation was performed for the finished device, and no non-conformances nor manufacturing irregularities were identified.

• Brand Name: VAPR S90 W/ HAND CONTROLS
• 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: 22125021
• Report Number: 1221934-2025-01990
• Device Sequence Number: 15663952
• Product Code: GEI
• UDI-Device Identifier: 10886705020935
• UDI-Public: (01)10886705020935(10)U2306059(17)260531
• 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,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 Expiration Date: 05/31/2026
• Device Catalogue Number: 228370
• Device Lot Number: U2306059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/20/2025; 08/07/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/23/2025; 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown