MAUDE Adverse Event Report: DEPUY MITEK LLC US COOLPULSE 90 ELECTRODE WITH HAND CONTROLS; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 228147

Device Problems Electrical /Electronic Property Problem (1198); Device Contamination with Chemical or Other Material (2944); Suction Failure (4039)

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

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 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.Additional narrative: udi: (b)(4).Investigation summary: the device was received and evaluated.Visual inspection revealed that the electrode is in normal use condition.The cable is in good condition as well as the connector and pins.The suction tube shows saline residues.The active tip shows signs of activation.When connected to the test generator, the electrode was immediately recognized.When performing the functional test, the ablation was not able to work, output shorted error was displayed.The electrode will be sent to the manufacturer for further analysis.The vapr clplse90 electrode w hand cntrls was evaluated by the manufacturer with the following results: the device has not been returned in its original packaging.The active tip is in a used condition, with evidence of activation and tissue debris around the active tip and in the suction port.Residue visible in the suction tube.No visible damage to the device shaft, handle, cable or plug.The electrical test was performed, as a result, the hipot active return test failed.The functional test was performed, the flow test, activation and post activation flow test failed.From our investigation we were able to confirm the customer reported issue.The device failed electrical hipot and functional testing displaying an output shorted error caused by an insufficient glue coverage between active tip and active suction assembly.The failure mode seen is consistent with previous complaint devices investigated under capa to prevent recurrence of this failure mode which are detailed below: 1.Update of the assembly aids 588060 and dn0012950 to further emphasize critical gluing process, to add image in appendix to highlight critical gluing instructions and add this to gluing station as visual aid.Additionally, training videos were embedded into assy aids to further support gluing processes in-line with best practice assembly method.2.Retraining of all operators that are completing id60 within cr1 and cr2 against assembly aid 588060 & dn0012950.The complaint device was manufactured in october 2021 which was prior to these corrective actions.A dhr review has been performed for the complaint device lot number u2109105; no issues (ncrs or deviations) with the manufacturing process have been indicated.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.

Event Description

It was reported by a healthcare professional in chile that during a rotator cuff repair procedure on an unknown date, it was observed that the coolpulse 90 electrode with hand controls device had a short circuit generating an alert and blocking the handpiece.During in-house engineering evaluation, it was determined that the suction tube on the device showed saline residues and when performing the functional test, the ablation did not and an output shorted error was displayed.Another like device was used to complete the procedure with a delay of 10 minutes.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: COOLPULSE 90 ELECTRODE WITH HAND CONTROLS
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• 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: 16001546
• MDR Text Key: 308179094
• Report Number: 1221934-2022-04019
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K113545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 228147
• Device Catalogue Number: 228147
• Device Lot Number: U2109105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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