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 10/01/2023

Event Type  malfunction  

Event Description

It was reported by the sales rep that during an unspecified arthrocopy procedure on (b)(6) 2023 the vapr tripolar 90 suction elect device suction did not work correctly due to clogging after five minutes.Another like device was used to complete the procedure.There was no 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: e3: reporter is a j&j sales representative.H4: the device manufacture date is unknown.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.

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 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.H4: the device manufacture date was unknown in 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 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: the investigation has been updated to reflect the correct information: investigation summary according to the information provided, it was reported that he suction of the vapr tripolar did not works correctly and stopped completely due to clugging after already 5 minutes.The complaint device was received and evaluated in juarez lab.Visual inspection revealed that the cable is in good condition as well as the connector and pins.The electrode tip has activation signs, the suction tube was in a normal shape.The device will be sent to the supplier for further investigation.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 and functional test of the device were performed, as a result; the device tip was in used condition with tissue debris around the active tip and in suction holes.The handle assembly as well as the cable and plugs were in good condition.Procedural residue visible in suction tube.The device passed successfully the electrical test.Functional testing failed in flow rate before and after activation.A dhr review has been performed for lot u2306073 (jul 2023); no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.The customer stated that the device had 'the suction of the vapr tripolar did not works correctly and stopped completely due to clogging after already 5 minutes'.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 reported device, 795000, vapr tripolar 90 suction electrode (225028) has been evaluated by atl uk team, successfully passing all electrical checks.It has also passed the majority functional checks however it was found to fail flow specifications due to a build-up of tissue debris at the distal end of the device which couldn't be 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 suction failure mode has been reviewed against the systems risk assessment document (b)(4), the highest identified risk within 892007 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 anaesthetic extended period of time.The severity risk category is 'minor'- results in temporary injury or impairment not requiring professional medical attention.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.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; raymham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17974710
• MDR Text Key: 326130140
• Report Number: 1221934-2023-03809
• 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,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• 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: U2306073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2023
• 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?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1