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  

Event Description

An olympus employee reported on behalf of the customer, connection issues and forceps adjustment malfunctioning with the evis lucera ultrasound gastrovideoscope.There was no report of patient harm associated with this event.During incoming inspection, it was determined foreign matter came out of the forceps channel.This mdr is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegations of connection issues and forceps adjustment malfunctioning were not confirmed.In addition to the finds reported in b5, due to damage on acoustic lens, water tightness was lost.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.Adhesive on bending section cover was detached.The scope connector was corroded due to water leakage.The electrical connector was corroded due to water leakage.The ultrasound connector of contact pins was corrosion.The connecting tube, acoustic lens, switch button 1, switch button 2, switch box and objective lens was scratched.Due to damage on ultrasonic probe, displayed ultrasound image was defective with missing elements.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

Additional information was provided regarding this event.The failure occurred in the middle of an unspecified procedure.The procedure was completed using the subject device.There was no delay or patient harm associated with this event.The customer was able to clean, disinfect and sterilize the subject device prior to requesting repair.It is unknown when the foreign object adhered to the scope.There was no time lag between the end of clinical use and the start of pre-cleaning.Water was cucked from the forceps/suction channel.There were no abnormalities in the accessories used for reprocessing.It is unknown if the endoscope was placed in cleaning solution.The air/water nozzle was wiped/brushed with a gauze, brush, or sponge.The forceps channel was brushed.

Manufacturer Narrative

This report is being supplemented to provide additional information, based on the legal manufacturer's 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, it is likely, the foreign material occurred, due to insufficient cleaning.However, a specific root cause could not be identified.In addition, the type of foreign material could not be identified.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: 16000693
• MDR Text Key: 308155370
• Report Number: 3002808148-2022-05347
• 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,Followup
• Report Date: 03/09/2023

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: 11/17/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 12/26/2022; 02/14/2023
• Supplement Dates FDA Received: 01/24/2023; 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2014
• 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