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 11/20/2023

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 mitek or its employees that the report constitutes an admission that the device, 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.E3: reporter is a j&j sales representative.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported by the sales rep in switzerland that during a rotator cuff repair procedure performed on (b)(6) 203 it was observed that the vapr tripolar 90 suction elect electrode clogged after approximately 10 minutes and subsequently stopped working.The device was immediately replaced with a new one and the operation could be continued.It was reported that with the second device, the external suction was increased slightly, and the blockage no longer occurred.There was a 3-minute delay in the procedure reported.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 mitek or its employees that the report constitutes an admission that the device, 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: 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.

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 : visual inspection revealed that the external aspect of the device does not show structural anomalies.The electrode tip show activation signs.The device will be sent to the supplier for further investigation.The visual inspection and functional test of the device were performed, as a result; the device was returned without its packaging, the tip does not show anomalies, however procedural debris can be seen in suction holes.The handle, cable and plug assembly were in good condition.The device passed successfully the electrical checks.The device failed the flow test before and after activation.Ablation and coagulation function worked as intended.A dhr review has been performed for the device and no issues with the manufacturing process have been indicated which might explain the failures observed.The customer stated that after ten mins of the operation the suction of the tripolar stopped working immediately.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 before or after activation.The reported tripolar 90 suction electrode was analyzed by the evaluation team and was found to be blocked by procedural debris.It was not possible to remove the blockage during the evaluation process.The device passed all electrical checks.It failed the flow rate tests before and after activation and passed the rest of functional checks.No manufacturing defect was found with the returned device.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).Based on a review of the evaluation results, product risk analysis and taking in consideration that after adjusting the suction settings no issue was reported while using an electrode of the same model as the reported, no initial containment action related to the individual complaint is recommended this time.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• 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 (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: 18261250
• MDR Text Key: 329665747
• Report Number: 1221934-2023-04374
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: 225028
• Device Lot Number: U2307005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 01/03/2024; 02/16/2024
• Supplement Dates FDA Received: 01/09/2024; 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1