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

Catalog Number 225028

Device Problem Infusion or Flow Problem (2964)

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

Event Date 01/07/2024

Event Type  malfunction  

Event Description

It was reported by a healthcare professional in switzerland that during a shoulder arthroscopy procedure on (b)(6) 2024, it was observed that the suction on the vapr tripolar 90 suction elect device clogged-up after some minutes and did not work.Another like device was used to complete the procedure.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.H10 additional narrative: udi: (b)(4).H4: 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.

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 device manufacture date was reported as unknown on the initial report; and has been updated accordingly.

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 the alleged device was received and evaluated.Visual inspection of the vapr tripolar 90 suction electrode device revealed that it had brown stains on the tip.The shaft, handle, cable and plug did not show any signs of damage.The device was sent to the manufacturer for further evaluation.A visual inspection of the device was performed; and determined that it was not in its original packaging.Tip was in a used condition with tissue debris around the active tip and in the suction holes.Procedural residue was visible in suction tube.The customer stated that the suction clogs after some minutes and suction does not work.Visual inspection recorded that the suction holes were blocked by tissue debris.The complaint was substantiated with the device being unable to achieve the minimum flow specification.The blockage was at the distal end of the device and caused by tissue debris.The returned device passed electrical tests.The device was found to pass the the hand switch activation test, however the device failed the flow specifications both before and after activation.Suction remained blocked after activation so additional unblocking techniques using syringe was attempted.This was unsuccessful in clearing the blockage and the device remained blocked.A thin gauge wire was fed through the suction tube to locate the blockage.The blockage was located at the distal end underneath the active tip.From internal investigation with the returned complaint device, we were able to confirm the customer report that the electrode suction would not work to the required specification.The device was found to fail flow specifications both before and after activation due to a build-up of tissue debris in the distal end of the electrode which could not be removed during the investigation.The investigation shows the blockage experienced by the end user is confirmed and can be attributed by 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.A manufacturing record evaluation was performed; and no related non-conformances were identified.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.

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 availale for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, notdiagnosis.H10 additional narrative: investigation summary: the complaint device is not being returned, 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 lot number (u2309128), 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 appropriate.Device was used for treatment, not diagnosis.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: 18552301
• MDR Text Key: 333358140
• Report Number: 1221934-2024-00192
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705023103
• UDI-Public: 10886705023103
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• 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: U2309128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2023
• 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