MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VIDEOSCOPE CABLE EXERA II

Model Number	MAJ-1430
Medical Device Problem Codes	Break (1069); Erratic or Intermittent Display (1182); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the scope cable was broken.The issue was observed during set up / inspection for use.The third-party distributor confirmed that the spiral cable was broken in front of the electrical connector and its image was uncertain.The damage was reportedly caused by improper use.Repair was not possible and disposal of the cable was suggested.There was no patient involvement.
Additional Manufacturer Narrative
B3: date of event is unknown.Additional information will be provided if available.The device was not returned to olympus for inspection.However, the third-party distributor repair center was able to confirm the customer failure.A definitive root cause could not be identified.Based on the results of the investigation, the complaint was confirmed.The most probable cause of the complaint is cause traced to failure to follow instructions.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEOSCOPE CABLE EXERA II
• Common Device Name: SCOPE CABLE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50694075
• Report Number: 3002808148-2026-31624
• Device Sequence Number: 18540668
• Product Code: FET
• UDI-Device Identifier: 04953170214509
• UDI-Public: 04953170214509
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K051645
• 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,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 Model Number: MAJ-1430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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