MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problems Break (1069); Device Reprocessing Problem (1091); Poor Quality Image (1408); Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was inspected at (b)(4).The subject device was checked, and it was confirmed the reported phenomena.It was looked like which may have occurred due to physical stress for the cut on the on the probe unit and insufficient cleaning by user handling for the foreign object on the forceps elevator.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at (b)(4), it was found the deep cut on the probe unit of the subject device which reached to the glue-layer, and the forceps elevator of the subject device had the foreign object.The subject device had been returned to olympus india for repair as no images were available.The occurrence date of the event is unknown.There was no patient injury associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The root cause of the reported phenomena could not be identified.[considerations] it was highly possible that any of these phenomena occurred after the subject device was shipped.But since the subject device was not returned, the root causes could not be identified [investigation results] >the forceps elevator of the subject device had the foreign object -by checking the image from the inspection of olympus india, it was confirmed that the reported phenomena occurred in the relevant part.-the subject device was not sent to the manufacturing site, and the information obtained was only images.-it was reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.-from these facts, it was possible that the reported phenomenon occurred later, but it was not possible to identify the adhered foreign object.>the deep cut on the probe unit of the subject device which reached to the glue-layer -by checking the inspection report of olympus india, it was confirmed that the reported phenomena occurred at the relevant part.-the subject device was not sent to the manufacturing site, and the information obtained was only images.-it was reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.-from these facts, it was possible that the reported phenomenon occurred later, but it was not possible to identify the cause of the damage.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.A review of the device history record found no deviations that could have caused or contributed to the image issue.Based on the results of the investigation, a definitive root cause could not be determined.However, the following are the potential causes: damage to the charge coupled device (ccd) unit; damage or deformation of the connector ; movable l-range sliding error that occurred in the zoom scope; blurred image occurred within the allowable range.The event can be detected/prevented by following the instructions for use: operation manual; inspection of the endoscopic system; operation manual.Important information ¿ please read before use.Warnings and cautions: during the device evaluation, service found that due to damage on charge coupled device (ccd) unit, the specified resolving power was not obtained.Due to damage on ultrasonic cable, displayed ultrasound image was defective with missing elements.Due to deformation of nozzle, the water removal ability did not meet the standard value.Due to clogging of water suction tube, balloon suction volume did not meet the standard value.Due to a scratch on acoustic lens, insulation resistance value did not meet the standard value.There was no electrical continuity due to damage to the scope connector.The distal end had a scratch.There was a leak due to deformation of the scope connector.The objective lens was chipped, and the adhesive on the bending cover (a-rubber) was chipped/detached, and the a-rubber had clotting protein.The suction cylinder was shaved, the grip and universal cord were scratched, and the color ring was cracked.Per the legal manufacturer, these other device issues identified by service have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.Olympus will continue to monitor field performance for this device.

Event Description

The subject device was received at an olympus service center for evaluation for a reported image problem [no ultrasound image was displayed on the monitor].There was no patient or user injury reported.During inspection and testing, service found foreign material in the forceps elevator, which was previously reported in the initial mdr.This report is being submitted to include the malfunction reported by the facility [no ultrasound image displayed on the monitor].

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 3002808148.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• 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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12932221
• MDR Text Key: 281759504
• Report Number: 8010047-2021-15554
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170341793
• UDI-Public: 04953170341793
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/08/2024

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
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 12/24/2021; 11/07/2021; 05/08/2024
• Supplement Dates FDA Received: 01/21/2022; 04/11/2023; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• 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