MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL COOLPULSE CURVE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	225031
Medical Device Problem Codes	Misconnection (1399); Blocked Connection (2888); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip labrum repair on hip joint procedure, an attempt was made to connect a coolpulse curve device to the vapr vue generator device and use was attempted, but the message "invalid" was displayed and the coolpulse curve was not connected.It was reported that the power was switched off and on, the coolpulse curve was loaded and became usable for awhile, but after just a few seconds of operating the foot switch, the display immediately changed to "invalid" and the connection became impossible.Further attempts were made to power the device off and on, but the coolpulse curve still did not connect properly.As the surgery could not be continued, a different type of handpiece probe was tried and was able to connect without any problems.The surgery continued using this and was completed without further problems.There was no surgical delay and no harm to the patient.No further information is available.Report 2 of 2 for (b)(4).
Additional 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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.
Additional 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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: the actual device was returned for evaluation.However, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once investigation has been completed, a follow-up report will be submitted accordingly.
Additional 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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the device comes in used condition.No structural anomalies were found.The device was connected to a test generator; the electrode was immediately recognized.The device was tested on hand buttons mode and foot switch mode.The coagulation was set to the highest value and ablation to the highest value for one continuous minute each one.The device performed as intended.No issues were found.The overall complaint was not confirmed as the observed condition of the coolpulse curve would have not contributed to the complained device issue.Based on the findings, the investigation could not draw any conclusions and no potential cause about the reported event can be established since the device passed the visual and functional testing.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: a manufacturing record evaluation was performed for the finished device number, and no non-conformances were identified.

• Brand Name: COOLPULSE CURVE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle CH-02 400; SZ CH-02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 23025392
• Report Number: 1221934-2025-03414
• Device Sequence Number: 9820304
• Product Code: GEI
• UDI-Device Identifier: 10886705027958
• UDI-Public: (01)10886705027958(10)U2410008(17)271028
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial 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
• Operator of Device: Health Professional
• Device Catalogue Number: 225031
• Device Lot Number: U2410008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 09/22/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 09/17/2025; 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown