MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR COOLPULSE90 ELECTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 228146

Device Problems Electrical /Electronic Property Problem (1198); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  malfunction  

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.Device was used for treatment, not diagnosis.Udi: (b)(4) incomplete.The expiration date is currently unavailable.The device manufacture date is currently unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the healthcare professional in australia that during an unknown procedure on (b)(6) 2024, it was observed that the coagulation on the vapr coolpulse90 electrode stopped working while in use.Another like device was used to complete the procedure with a delay of five minutes.There were no adverse patient consequences reported.No additional information was provided.

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.Device was used for treatment, not diagnosis.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.Device was used for treatment, not diagnosis.H4: the expiration date and device manufacture date were reported as unknown on the initial report; and have been updated accordingly.Therefore, udi: (b)(4).

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.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary (b)(4).The product was returned to mitek for evaluation.Mitek then conducted visual and functional inspection of the device received.The complaint device was received and evaluated in juarez lab.Visual inspection revealed that the device was in used condition.Slight marks of foreign matter were observed on the handle, presumably biological matter.The cable is in good condition as well as the connector and pins.The electrode tip shows activation signs.The rest of the device was in a normal condition.To test its functionality, the electrode was connected to the vapr vue test generator, and it was recognized immediately, the default values were displayed correctly (coolpulse 90, ablate power 220 and coagulate power 80), no alert messages were displayed.Also, a vapr 3 test footswitch was used; the ablation function was activated several times in its maximum power (maximum ablate power 380) during one minute each test, and it worked as intended.Under coagulation function, the electrode was activated several times in its maximum power (maximum coagulate power 160) during one minute each test, and the coagulation function work as expected, no anomalies could be identified.The overall complaint was unconfirmed as the observed condition of the vapr coolpulse90 electrode would not contribute to the complained device issue.Based on the investigation findings and since the coagulation function was activated without anomalies, it was conclude that there is no enough evidence to adjudicate a root cause for the issue experienced by the customer.Therefore, it has been determined that no corrective and/or preventative action is required.As part of depuy synthes mitek 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 : a manufacturing record evaluation was performed for the finished device (u2308017), and no non-conformances were identified.

Event Description

This is report 1 of 2 for (b)(4).It was reported by the healthcare professional in australia that during an unknown procedure on (b)(6) 2024, it was observed that the coagulation on two vapr coolpulse90 electrode devices stopped working while in use.Another like device was used to complete the procedure with a delay of five minutes.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VAPR COOLPULSE90 ELECTRODE
• Type of Device: 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: 18810838
• MDR Text Key: 337073264
• Report Number: 1221934-2024-00660
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228146
• Device Lot Number: U2308017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1