MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR COOLPULSE90 ELECTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 228146

Device Problem Infusion or Flow Problem (2964)

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

Event Date 11/10/2023

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 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 belgium that during a rotator cuff (rc) repair surgical procedure on (b)(6) 2023 it was observed that there was obstruction of the vapr coolpulse90 electrode/suction device did not work anymore.It was reported that to resolve the issue, the suction was reattached.The procedure was prolonged only for 3 minutes.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 this medwatch, a supplemental medwatch report 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 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: investigation summary: the device was received and evaluated.Visual inspection of the device revealed that it was not received in its original packaging.The shaft, handle, cable and plug did not show any signs of damage.The electrode was sent to the manufacturer for further evaluation.A visual inspection of the device was performed; as a result, device has not been returned in the original packaging.Tip has procedure remains visible and has signs of activation.Suction hole appears quite full of charred tissue.No residue visible in suction tube.The complaint device was manufactured in aug 2023.A device history review (dhr) has been performed for the complaint device; no issues with the manufacturing process have been indicated which might explain the failures observed.The customer stated that suction was not working correctly.The returned device passed electrical tests.The device was found to pass flow specifications both before and after activation, however the performance of the flow rate was found to fluctuate and drop off due a build-up of tissue debris at the distal end of the electrode.The tissue debris was removed during the investigation due to increased suction pressure and also activating the electrode at the same time, which returned the flow rate to normal.The investigation shows the incorrect function of the suction experienced by the end user can be attributed procedural tissue debris.The product instructions for use (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, the highest identified risk for failure modes that are equivalent to the complaint failure mode is loss or deterioration of function - reduced/blocked irrigant flow.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.For this scenario a pre mitigation risk is 'minor' and 'frequent' and rated as as low as reasonably achievable (alra).Analysis shows that the frequency is below the anticipated rate of failure.Therefore, the severity and frequency are as anticipated in the risk documentation and remain as alra.As the grid rating is alra and this is a low occurrence incident, no further action is required at this time 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.

• Brand Name: VAPR COOLPULSE90 ELECTRODE
• 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: 18230280
• MDR Text Key: 329274053
• Report Number: 1221934-2023-04318
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705010080
• UDI-Public: 10886705010080
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K113545
• 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: 228146
• Device Lot Number: U2308016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 01/11/2024; 03/13/2024
• Supplement Dates FDA Received: 01/18/2024; 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1