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

Catalog Number	228147
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during in-house engineering evaluation, it was determined that the vapr clplse90 electrode w hand cntrls device had foreign substance/debris/cleaning/sterilization and would not coagulate.It was initially reported that during an arthroscopic ligament reconstruction procedure, it was discovered that the device did not work.There were no delays in the surgical procedure.It was reported that a spare device was used to complete the surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.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: e1: the reporter¿s complete facility address was not provided.Investigation summary the product was returned to depuy synthes for evaluation.Visual inspection of the returned device revealed the overall device surface with signs of usage.Additionally, the tip had foreign matter, presumably biological matter.No other anomalies were noted.A functional test was performed by activation of the device; it was connected to a test generator.The ablation function and the coagulation function were activated several times in their maximum power (cp 380 for ablation and cp 160 for coagulation) for one minute each test, and they did not work as intended for both buttons.The supplier performed an evaluation with the following results: device received in its original packaging.The tip was used, with tissue residue inside the active tip and manifold.The handle, cable and plug were in good condition with some residue visible in suction tube.There were no ncrs or deviations raised during the manufacturing process of this device.The customer stated that ¿it was reported that during the surgery, the device could not work.¿ the electrode successfully passed the electrical tests; however, it failed during hand switch activation.There was no response when attempting to use the ablation, coagulation, or mode functions.As none of the buttons were responsive on the handle during checks, the halves were opened to inspect the internals.Inspections showed that there was evidence of saline ingress on the return shaft/clip and exterior of the rubber button sleeve.The rubber button sleeve was removed, revealing evidence of internal saline ingress on the moulding.In further investigation coagulation activation was repeated without the rubber button sleeve.Initially, there was no response; however, the ablate and mode buttons began to activate intermittently afterwards.As the coagulation function was still not operating, the switch button and dome were cleaned using a cotton bud to assess whether this would restore functionality.This resulted in successful activation.Additionally, positive pressure was applied to the suction pathway at the enteral adaptor, with the distal tip blocked - no leaks were recorded.However, when positive pressure was applied while the distal tip was submerged in water inside the pressure rig, with the suction tube blocked - leakage observed at the proximal end of the return tube.Due to an increase of complaints reported for this device which include observations of saline ingress into the handle and onto switch components, a capa has been raised investigate the issue surrounding intermittent operations/stuck button complaints the customer complaint can be substantiated.The overall complaint was confirmed as the observed condition of vapr clplse90 electrode w hand cntrls would have contributed to the complained issue.Based on the investigation findings, the potential cause is undetermined.This product issue was identified during the investigation by the supplier.This product issue will be addressed through the supplier quality system.Depuy synthes will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.Device history review a manufacturing record evaluation was performed for the finished device u2504015 number, and no non-conformances were identified.

• Brand Name: VAPR COOLPULSE
• 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: 25348136
• Report Number: 1221934-2026-02345
• Device Sequence Number: 13449016
• Product Code: GEI
• UDI-Device Identifier: 10886705010097
• UDI-Public: (01)10886705010097(10)U2504015(17)280427
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K100638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: 228147
• Device Lot Number: U2504015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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