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

Model Number GF-UCT260

Device Problems Device Contamination with Chemical or Other Material (2944); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.The forceps jaw was damaged due to physical stress.In addition to evaluation, due to wear of angle wire, bending angle in up direction did not meet the standard value.Due to wear of angle wire, the play of up/down knob was out of the standard value.The adhesive on the bending section cover was detached.The adhesive on bending section cover had a chip.The adhesive on the bending section cover had a crack.Scope connector had corrosion due to water leakage.The switch button 1 had a scratch.The distal end had stain.The objective lens had a scratch.Reprocessing of subject device: the customer was not able to clean, disinfect and sterilize the subject device prior to sending it to olympus.The device was not reprocessed due to partial damage to the forceps hole.User facility did not know when the foreign object adhered to the scope.There was no delay between the end of clinical use and the start of pre-cleaning.The forceps elevator was raised and lowered three times by turning the elevator control lever while immersed and aspirated.There were no abnormalities in the accessories used for reprocessing.The endoscope was immersed in a detergent solution.The forceps elevator was brushed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus employee reported on behalf of a customer, the evis lucera ultrasound gastrovideoscope had a broken forceps hole.There was no reported patient harm associated with this event.During incoming inspection, foreign object was attached to forceps elevator wire due to insufficient cleaning.This medwatch 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.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 foreign material observed adhering to the elevator forceps wire could not be identified and the root cause of the issue could not be determined, however, the customer reported that the device was returned to olympus without being reprocessed at the facility due to damage to the forceps hole.The event may be prevented by following the instructions for use sections below: ¿·chapter 6 application and conditions of cleaning, disinfection and sterilization¿ ¿·chapter 7 cleaning, disinfection and sterilization procedures¿ 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: 16645881
• MDR Text Key: 312523375
• Report Number: 3002808148-2023-03160
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• 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: 03/03/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2015
• 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