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

Model Number GF-UCT260

Device Problem Residue After Decontamination (2325)

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

Event Type  malfunction  

Manufacturer Narrative

During examination, the customer's reported issue was confirmed; a pin hole was observed in the instrument channel.The channel was blocked due to the foreign material found at this area.Examination also showed the bending section cover's adhesive was chipped, cracked and partially detached; the control unit was corroded; the light guide cover glass was scratched; the ultrasound transducer was corroded; the objective lens and light guide lenses were both scratched; and the connecting tube was scratched.Functional testing showed the up direction's bending angle was out of specifications and the up/down knob had excess play; both issues occurred due to a worn angle wire.In addition, the ultrasonic image was incomplete due to probe damage.The investigation is ongoing.A supplemental report will be submitted upon completion of investigation.

Event Description

The customer reported to olympus medical that the evis lucera ultrasound gastrovideoscope leaked.The device was returned to olympus medical for evaluation.During evaluation, the foreign material was found at the forecps channel.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.No adverse effects to patient reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 of the event was unable to be identified.It is likely that the foreign object could not be removed due to physical damage of the device.A pinhole was confirmed in the forceps channel.It was unclear whether the reprocessing was performed according to the instructions for use (ifu).The event may be prevented by following the descriptions in the following items in the instructions for use (ifu): [instruction manual evis lucera ultrasonic gastrovideoscope olympus gf type uct260] chapter 6 application and conditions of cleaning, disinfection and sterilization.Chapter 7 cleaning, disinfection and sterilization procedures.1) "when the curved portion of the endoscope is greatly curved, the force required to insert/withdraw the instrument increases.If it is difficult to insert/remove the treatment instrument, return the bending angle of the bending part to a point where insertion/removal can be done without difficulty.Forcible insertion/removal may damage the forceps channel and the instrument." 2) "make sure that the tip of the treatment instrument is closed or retracted into the sheath, and then slowly insert or withdraw it into the forceps plug.Also, do not open the tip of the treatment instrument or pull it out of the sheath while it is being inserted into the forceps channel of the endoscope.The forceps channel and treatment tools may be damaged." 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 (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17430110
• MDR Text Key: 321182268
• Report Number: 3002808148-2023-07737
• 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: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• 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: 07/03/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• 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