MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR TRIPOLAR 90 SUCTION ELECT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 225028

Device Problem Device Remains Activated (1525)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

It was reported by the sales rep in japan that during an arthroscopic rotator cuff repair procedure on (b)(6) 2024, it was observed that the vapr tripolar 90 suction electrode device kept running.Another like device was used to complete the procedure successfully within 30 minutes delay.There were no adverse patient consequences nor surgical delay 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.Udi: (b)(4).E3: reporter is a j&j sales representative.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.

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.Investigation summary the complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device u2306024, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

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 apropriate.Device was used for treatment, not diagnosis.Investigation summary: the device was received and evaluated in juarez laboratory.Upon visual inspection revealed that vapr tripolar 90 suction elect was in normal use condition.The cable is in good condition as well as the connector and pins.The suction tube does not show saline residues.The active tip does not show signs of activation.A functional test was performed, the device was connected to the test generator, the electrode was immediately recognized.The ablation function was activated using the hand controls and footpedal, the electrode did only work when using the footpedal.The coagulation function was activated using the hand controls and footpedal, the electrode did work.The electrode will be sent to the manufacturer for further evaluation.A visual inspection of the device was performed; as a result, device was not returned in original packaging.Device was in a used condition with residue around active tip.Saline residue was visible in the suction tube.The device passed the electrical testing.The device failed the handswitch activation functional test for the ablate function.Button 1 and button 2 were not working correctly the complaint device was manufactured in jun 2023.A dhr review has been performed for the complaint device lot number u2306024.No issues (ncrs or deviations) with the manufacturing process have been identified.The customer stated that 'the electrode in question kept running from the middle of use.The surgeon felt it was dangerous to continue using so that a new same device was used for surgery'.Testing did not substantiate the customer claim that the device would keep running, but it did show that two of the ablate buttons would not function.Inspection of the individual buttons did not reveal any visual faults.When the individual buttons were pressed without boot, all functioned correctly.After numerous presses it was concluded the force to press the buttons needed to be directed in the center of the button on the faulty switches.If the force was applied off center, then inconsistent function was recorded.Removal of the rubber boot revealed moisture droplets along with an area of unknown substance on the shaft heat shrink.The overall complaint was unconfirmed as the observed condition of the vapr tripolar 90 suction elect would not have contributed to the complained issue.Based on the investigation findings, the potential cause could be traced to component failure.At this point in time, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history lot: a review of the batch manufacturing records was conducted, and no related non-conformances were identified.

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

• Brand Name: VAPR TRIPOLAR 90 SUCTION ELECT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18695994
• MDR Text Key: 335257706
• Report Number: 1221934-2024-00475
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143475
• 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: Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 225028
• Device Lot Number: U2306024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• 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