MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL; ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)

Catalog Number	242437
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
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: 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.
Event or Problem Description
It was reported that during an unspecified surgery, the image of the device remained blurry even when focusing.There was no surgical delay and no harm to the patient.After surgery, when wiping the coupler, black oil was found on the lens.Although cleaning and sterilizing according to the instructions, the coupler lens gets heavily soiled.The sales rep have also received feedback suggesting that grease might be melting from the screw connection to the camera head.After cleaning the oil film, the image was clear and worked without problems.No further information was available.

• Brand Name: NA
• Common Device Name: ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)
• 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; la locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24681024
• Report Number: 1221934-2026-01210
• Device Sequence Number: 21274849
• Product Code: FEM
• UDI-Device Identifier: 10886705028610
• UDI-Public: (01)10886705028610
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 242437
• Device Lot Number: 2403CE0782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown