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 Device Damaged Prior to Use (2284)

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

Event Type  malfunction  

Event Description

This is report 1 of 2 for (b)(4).It was reported by the sales rep in taiwan that during an unknown surgery on an unknown date, it was observed that the coolpulse 90 electrode with hand controls device had no suction.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 medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Reporter is a j&j sales representative.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.

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 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.

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.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 does not show saline residues.The active tip is broken.The electrode will be sent to the manufacturer for further review.Manufacturer evaluation result for vapr clplse90 electrode w hand cntrls: the device has not been returned in its original packaging.No clear signs of activation.The active tip has fractured in half.The ceramic has also fractured.No other damage visible on the device.The electrical test and the functional test were not performed due to the condition of the device's tip.Manufacturer summary: we can confirm the damage as reported with the returned device and the electrode condition does appear to be consistent with reported event where the end user states the electrode was new out of the box as the electrode shows no signs of activation.A review of our quality records show no quality issues affecting either of these components.No other field complaints have been received from the lot.During manufacturing 100% visual inspection of the tip face at 10x magnification is performed which includes the inspection criteria of no chips or cracks or rough edges are allowed on the ceramic as per the inspection process the damage seen to the ceramic and active tip appears to be different from the previous breakages seen under capa investigation therefore is unlikely to have been caused by the same mechanism and we have been unable attribute an exact root cause.The electrode has also been reviewed and it was concluded the damage seen is likely to be attributed to impact forces (dropped electrode).A review of our complaint records over the last 12 months to assess the frequency of this defect and our analysis shows this defect is of low occurrence.The rating is a low occurrence incident, no further action is required at this time.Dhr review has been performed for the complaint device lot number and 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.

• 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: 15163837
• MDR Text Key: 302439316
• Report Number: 1221934-2022-02368
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705010097
• UDI-Public: 10886705010097
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• 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: U2111026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• 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