MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR TRIPOLAR90 SUCTION ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 225028

Device Problem Infusion or Flow Problem (2964)

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

Event Date 05/08/2023

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.Udi: (b)(4).Reporter is a j&j employee.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 affiliate in japan that during an arthroscopic rotator cuff repair procedure on (b)(6) 2023, it was observed that the suction on the vapr tripolar90 suction electrode device was stuck 30 minutes after the start of the operation.According to the report, the surgeon tried to improve by sending water through the electrode tip or suction port with a syringe but there was no improvement.Another like device was used to complete the procedure successfully within 30 minutes delay.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.H10 additional narrative: investigation summary - the complaint device was received and evaluated.Visual inspection revealed that the cable was in good condition as well as the connector and pins.The suction tube did not show structural anomalies.The electrode tip did not show clear signs of activation.For the suction testing, the electrode was sent to the manufacturer for further evaluation.The vapr tripolar 90 suction elect was returned to manufacturer for evaluation.The manufacturer conducted visual inspection and functional test of device received by customer.The visual inspection of the device was performed, as a result; the device was not returned in its original packaging, the active tip was in used condition with signs of debris around the active tip.There were tissue debris within the suction ports.The suction control valve was received in the closed position.No damage to the shaft, handle or cable/plug.Also, the electrical test was passed.When performing the functional test, the ablate function as well as the coagulation function were activated as intended.The flow test before activation failed.The customers device(s) were manufactured in (b)(6) 2022 a dhr review has been performed for lot u2205048; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Based on a review of the complaint investigation outcome no containment action related to the individual complaint is required.From our investigation we were able to confirm the customer report that the electrode suction was blocked with the returned device.The device was found to fail flow specifications due to a build-up of tissue debris at the distal end of the device which was removed during the investigation.The investigation shows the blockage experienced by the end user is confirmed and can be attributed procedural tissue debris.No manufacturing defect was found with the returned device.The product ifu cautions not to allow the electrode to become covered in tissue debris.If this occurs, use a new electrode.The product ifu warns electrodes will wear from normal use, dependent on factors such as length of use, high tissue removal rate, prolonged use against bony surfaces, prolonged use in saline, high power settings, and use with minimal suction or fluid management.Periodically assess electrode tip for wear and proper operation.Replace the electrode if excessive wear is noted.The suction failure mode has been reviewed against the systems risk assessment document 892007-du, the highest identified risk within 892007-du for failure modes that are equivalent to the complaint failure mode is loss or deterioration of function - reduced/blocked irrigant flow.Risk matrix line 1000 applies.Resulting in reduced visibility & increased procedure time - patient under anesthetic extended period of time.The severity risk category is ¿minor¿- results in temporary injury or impairment not requiring professional medical attention.For this scenario a pre mitigation risk of grid 10 and a post mitigation risk of grid 10 are stated, which is ¿minor¿ and ¿frequent¿ and rated as as low as reasonably achievable (alra).No further action is required at this time.The device as presented was found to be blocked at the distal end by tissue debris and therefore substantiating the customer complaint.Post activation the device successfully achieved the flow specification.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 appropriate.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.

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.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 TRIPOLAR90 SUCTION ELECTRODE
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• 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: 16995618
• MDR Text Key: 316484924
• Report Number: 1221934-2023-02145
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705023103
• UDI-Public: 10886705023103
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 225028
• Device Catalogue Number: 225028
• Device Lot Number: U2205048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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