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

Catalog Number	225031
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This is report 2 of 2 for (b)(4).It was reported that during an unspecified surgical procedure, two coolpulse curve devices were not coagulating fast enough with the electrodes for the past month.According to the reporter, the console was exchanged and different batch numbers were tried without success, and there were no issues with the console's screen tracking.It was reported that functioning was okay with the hooks.The procedure was delayed, though the exact duration of the delay was not specified.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in january 2026.All available information has been disclosed.
Additional 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.
Additional 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11: additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11: additional narrative: investigation summary the complaint device was returned to depuy synthes for physical evaluation.Visual inspection of the returned device found that the device comes in used condition.The active tip shows activation marks.The device will be sent to the manufacturer for further analysis.Manufacturing investigation result for coolpulse curve: the device was not received in original packaging, shelf carton box only.The tip is used, tissue debris in the active tip.Handle assembly is used, no misuse.Cable and plug are used, no misuse.Procedural residue visible in suction tube.Electrical checks: the device passed all parameters.Functional checks: the device failed flow rate test before activation.Observation of the tip during activation (ablate and coagulation) did not reveal any anomalies, functioning as expected.The customer's issue could not be replicated.Since this was not accomplished, the complaint cannot be substantiated.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 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 depuy synthes 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 lot number (u2509001), and no non-conformance was 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 SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24307835
• Report Number: 1221934-2026-00686
• Device Sequence Number: 18561847
• Product Code: GEI
• UDI-Device Identifier: 10886705027958
• UDI-Public: (01)10886705027958(10)U2509001(17)280831
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

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: U2509001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 04/15/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/17/2026; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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