MAUDE Adverse Event Report: Medos International SARL COUPLER AC FFL 19; Accessories, Photographic, For Endoscope (Exclude Light Sources)

Catalog Number	242437
Medical Device Problem Codes	Degraded (1153); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2026
Type of Reportable Event	Malfunction

• Brand Name: COUPLER AC FFL 19
• Common Device Name: Accessories, Photographic, For Endoscope (Exclude Light Sources)
• Manufacturer (Section D): Medos International SARL; 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 ; +1(908)386-3534
• MDR Report Key: 50670844
• Report Number: 1221934-2026-03997
• Device Sequence Number: 10153085
• Product Code: FEM
• UDI-Device Identifier: 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
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2022
• 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