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

Catalog Number 225028

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/25/2023

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.H10 additional narrative: e3: reporter is a j&j employee.(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 affiliate in japan that during an arthroscopic rotator cuff repair surgery for a rotator cuff tear on (b)(6) 2023, it was observed that the surgeon confirmed the metal part at the tip of the vapr tripolar90 suction electrode device was chipping.The surgeon commented that when using the electrode, they had been performing an exfoliating operation at a deep area, which may have put stress on the tip of the electrode.A possible cause other than the device was that since the surgery was being performed via debeyre-patte procedure, the operation was performed at the quite deep area, which may have put stress on the tip of the electrode.X-rays taken immediately after the surgery showed the metal fragment of the tip of the electrode, indicating that the tip of the electrode had broken off and remained inside the patient's body.The broken pieces were not successfully removed from the patient.There was no additional medical or surgical intervention required.It was reported that the patient¿s outcome was stable.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.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 the device has been evaluated, 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 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.H10 additional narrative: investigation summary
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> 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 revealed that the distal 50% of the active tip is missing, the cut return cap is blackened and scored, the return shaft has excessive scores and markings distal to the heatshrink, the heatshrink has scores and scratches along the shaftfor n75mm from distal end of heatshrink.The device passed all electrical test.Initially the flow rate was seen to be outside of specifications, however after a short activation with suction on, the flow path cleared, and the flow rate was measured within specification.The device showed signs of excessive use with many scores and scratches on the ceramic, return cap, and heatshrink.A dhr review of lot 02306024 (jun 2023) shows that no issues (ncrs or deviations) have been noted which might explain the failures observed during the manufacturing process.Based on a review of the initial investigation findings and the product ra no further action will be proposed this time.Visual inspection shows that half of the active tip is missing from the device also signs of excessive use have been spotted that aligns with the surgeon comment of il had been performing an exfoliating operation at the quite deep area, which may have put stress on the tip of the electrode, these observations are consistent with failures previously seen and investigated through capa.In addition to this, vapr tripolar 90 suction electrode ifu, has been reviewed and 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.At this point in time, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted 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: 18086064
• MDR Text Key: 327551890
• Report Number: 1221934-2023-04041
• 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
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• 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?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/12/2023
• 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
• Patient Age: 66 YR
• Patient Sex: Male