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  

Event Description

It was reported by the sales rep in switzerland that during an unspecified surgical procedure on (b)(6) 2023, the vapr tripolar 90 suction elect device suction stopped working immediately after about ten minutes of the operation.It was reported that cleaning of the tip did not help and the suction of the stryker neptune still worked.It was reported that with a new electrode it worked again normally.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted 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.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.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.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.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary 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 was received only with its outer box, the tip was found in good condition.Procedural debris can be seen in suction holes.The handle assembly as well as the cable and plugs were found good, some small indents on cable, no damage to insulation.Procedural debris in suction tube, indent on suction tube.The device passed the electrical checks.The device did not pass the flow rate test before and after activation, ablation and coagulation function worked as intended.A dhr review has been performed for the complaint device lot number u2307117.No issues (ncrs or deviations) with the manufacturing process have been identified which could attribute to the complaint in question.From our investigation we were able to confirm the customer report that the electrode suction would not work with the returned complaint device.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 indent observed on the suction tube is cosmetic only and has no impact on the performance of the device as the tube was still fully open.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, 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.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 low as reasonably achievable (alra).Based on a review of the investigation findings and risk documentation no correction action has been implemented.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 Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 18301353
• MDR Text Key: 330171257
• Report Number: 1221934-2023-04426
• 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
• Report Date: 12/06/2023

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: U2307117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 01/03/2024; 02/13/2024
• Supplement Dates FDA Received: 01/09/2024; 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2023
• 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