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

Model Number GF-UCT260

Device Problems Material Puncture/Hole (1504); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.It was found to be caused by a pinhole in forceps channel.In addition to the evaluation, the bending angle was insufficient due to elongation of the angle wire.The play of the angulation knob was out of specification due to elongation of the angle wire.Inside the operation part (grip) was corroded.Inside scope connector was corroded.Switch button 1 was scratched.Inside light guide hoses were corroded.Bending section cover adhesive was cracked.Image guide fiber hoses were scratched.Objective lens was scratched.The insertion tube became deteriorated.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the evis lucera ultrasound gastrovideoscope experienced air/water leakages during reprocessing.There was no report of patient harm associated with this event.During inspection of returned device, there was residual liquid and foreign matter within the forceps port.This mdr is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to update h4.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause could not be determined.It was confirmed that foreign material/residual fluid was found coming from the forceps channel, however, the specific material could not be identified.It is likely that the foreign material remained in the channel and could not be removed due to the physical damage to the forceps channel.There were no reported deviations from the instructions for use (ifu) regarding reprocessing.The event can be prevented by following the instructions for use (ifu) which state: "warning do not strike or drop the tip of the endoscope, soft part, curved part, operating part, universal code, or scope port.Do not bend, pull or twist the cable with a strong force.Damage to the device may result in injury to the body cavity, burns, bleeding, perforation, or dislodgement of parts." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15668533
• MDR Text Key: 306795593
• Report Number: 3002808148-2022-03517
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

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-UCT260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2012
• 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