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

Model Number 228147

Device Problem Infusion or Flow Problem (2964)

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

Event Date 05/18/2023

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 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.H10 additional narrative: udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by a healthcare professional in china that during a left arthroscopic shoulder joint cleaning surgery with rotator cuff repair procedure on (b)(6) 2023, it was observed that the coolpulse 90 electrode with hand controls device had no suction.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay 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 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 medwtch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device was received and evaluated in juarez lab.Visual inspection revealed that the device had the power cord was cut, and it was not returned.The tip shows signs of activation.The shaft, the buttons as well as the handle do not show structural anomalies.Saline residues were found in the suction tube.This device was sent to supplier for further investigation.The vapr clplse90 electrode w hand cntrls 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 device was not returned in the original packaging.The active tip looks in a used condition.There is no evidence of tissue inside the suction holes, saline residue visible in the suction tube and the device plug has been cut off.The electrical test was not performed due to the device plug being cut off.The functional test was limited to the flow test due to the device plug being cut off and the test was passed.The complaint could not be substantiated with the device successfully passing the flow rate test.A dhr review has been performed for lot u2212019; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Based on a review of the complaint investigation outcome no containment action related to the individual complaint is required.From our investigation we were unable to confirm the customer reported issue that the electrode could not suction.Testing at gyrus medical shows the returned device was found to pass suction flow rate testing.Due to the condition of the device electrical and functional testing could not be performed.During flow rate testing he complaint device suction function was found to meet the manufacturers specification; therefore, no further investigation is possible regarding the returned complaint device.The root cause of the customer reported suction problem could not be determined.At this point in time, no corrective action is required, and no further action is warranted.However, 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.

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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 17074853
• MDR Text Key: 317301072
• Report Number: 1221934-2023-02310
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705010097
• UDI-Public: 10886705010097
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup,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 Model Number: 228147
• Device Catalogue Number: 228147
• Device Lot Number: U2212019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 06/07/2023; 08/07/2023; 08/09/2023
• Supplement Dates FDA Received: 06/08/2023; 08/08/2023; 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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: 65 YR
• Patient Sex: Male