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

Model Number MAJ-1430

Device Problems Erratic or Intermittent Display (1182); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2024

Event Type  malfunction  

Event Description

It was reported, the videoscope cable experienced a video connection issue and video interference.The unspecified diagnostic procedure was prolonged for 10 minutes.The procedure was completed using a replacement device.There was no report of medical intervention being required or patient harm associated with this event.

Manufacturer Narrative

To date, the device has not been returned.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record (dhr) was unable to be reviewed for this device however, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation and because the subject device was not returned for evaluation, the reported event could not be confirmed and a root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEOSCOPE CABLE EXERA II
• Type of Device: 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 ; 5082077661
• MDR Report Key: 18616953
• MDR Text Key: 334230495
• Report Number: 3002808148-2024-00970
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170214509
• UDI-Public: 04953170214509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1