MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. 4K CABLE 8.5M

Model Number MAJ-2254

Device Problem Poor Quality Image (1408)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

As reported for this event by the customer, during a therapeutic laparoscopic colectomy procedure, part of the 4k image was flickering due to the disconnection of the device.The procedure was completed with another similar device.There is no harm or adverse impact to the patient.

Manufacturer Narrative

The device is returned and an evaluation completed for it.Upon inspection and testing, it was observed that there was no red image yielded.When connected and operated according to the instruction manual, there are no other abnormalities than this.There was no abnormality in the appearance of the device.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

Addendum jul 26, 2022: the event occurred during preparation for use prior to the procedure.There is no patient involvement.The device was replaced with another similar device for the set up, and the intended procedure was completed with no delay.

Manufacturer Narrative

Additional information has been received from the customer.This supplemental report is being submitted to provide this information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A definitive root cause for this issue was not established.However, it is probable that the image problem occurred because the device¿s cable was broken.The cable was also partially bent and showed signs of the coating/adhesive peeling.These damages may have resulted from a mishandling of the device.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿do not bend, pull, or twist the power cord.Equipment damage including separation of the power plug and disconnection of the cord wire as well as a fire or an electric shock may result.¿ olympus will continue to monitor field performance for this device.

• Brand Name: 4K CABLE 8.5M
• Type of Device: CABLE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15084402
• MDR Text Key: 304722115
• Report Number: 3002808148-2022-00208
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170374685
• UDI-Public: 04953170374685
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: OTV-S400