MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL ALL-IN-ONE CCU+LIGHT ROW; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	242302
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to an unknown arthroscopic procedure, that the all-in-one ccu+light row device the light source was not able to turn on, so the surgeon could not set the white balance.The surgeon plugged in the camera head and light cable and tried to turn on the light source using the button on the camera head, but no light came on.Another device was used to complete the procedure.There was a 30 min.Surgical delay in the procedure reported.There were no adverse patient consequences reported.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, and no conclusion can be drawn at this time.According to the information received, it was reported that this was an unknown surgery performed, before the surgery, the light source was not able to turn on, so the surgeon could not set the white balance.The surgeon plugged in the camera head and light cable and tried to turn on the light source using the button on the camera head, but no light came on.The surgeon tried to set the white balance in that state, but the spinning icon just wouldn't come on and i couldn't set it.(the screen remained black because there was no light.) the surgeon unplugged the camera head and light cable, but the spinning icon in the color bar just wouldn't stop.Turning it on and off solved the problem.The complaint device was not returned to depuy synthes, therefore unavailable for a physical evaluation.A device history review was performed for the finished device serial number: (b)(6), and the certificate of conformance stated that the device was manufactured in compliance with the quality system release criteria.Based on the current available information, we cannot determine a root cause for the reported failure.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and 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 lot: a device history review was performed for the finished device serial number: (b)(6), and the certificate of conformance stated that the device was manufactured in compliance with the quality system release criteria.Device history batch: null device history review: a device history review was performed for the finished device serial number: (b)(6), and the certificate of conformance stated that the device was manufactured in compliance with the quality system release criteria.E1: the reporter¿s complete facility address was not provided.
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: h6.Investigation conclusions: added accordingly.

• Brand Name: ALL-IN-ONE CCU+LIGHT ROW
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24591480
• Report Number: 1221934-2026-01059
• Device Sequence Number: 9466866
• Product Code: GCJ
• UDI-Device Identifier: 10886705028702
• UDI-Public: (01)10886705028702
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 242302
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 06/19/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/31/2026; 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown