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

Model Number GF-UCT260

Device Problems No Display/Image (1183); Device Contamination with Chemical or Other Material (2944); Material Split, Cut or Torn (4008); Failure to Clean Adequately (4048)

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

Event Date 12/22/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of ultrasound image did not reflect was not confirmed.The allegation of scratches on the surface of the ultrasonic probe was confirmed.Acoustic lens had a chip.In addition, due to a pinhole on channel tube, 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.Adhesive on bending section cover had a crack.Ultrasonic transducer had corrosion.Mouthpiece was loose.Connecting tube had a scratch.Connecting tube had a wrinkle.Distal end had a scratch.Distal end had a dent.Due to wear of lock engagement lever, up/down knob could not be locked securely.Protector of universal cord on control section side had a scratch.Paint on air/water cylinder was peeled.Objective lens had a scratch.Objective lens had a crack.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.

Event Description

An olympus employee reported on behalf of the customer, the evis lucera ultrasound gastrovideoscope had scratches on the surface of the ultrasonic probe and ultrasound image did not reflect.There was no user or patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.During inspection and testing, distal end of the device had foreign material attached.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported device problem.The dhr confirmed that the subject device was shipped in accordance with the specifications.The root cause of no ultrasound image and scratches on the ultrasonic probe surface could not be identified.The foreign body could not be identified.The cause of the retained foreign body in the device could not be identified.The instruction for use provides the following: ¿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.

Event Description

Additional information was provided regarding this event.The event occurred during preparation for use.The intended procedure was a therapeutic endoscopic ultrasound fine-needle aspiration.There were no delays, and the procedure was completed using another device.There was no user 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.It is unknown what the foreign material is.There was no delay between the end of clinical use and the start of pre-cleaning.There were no abnormalities in the accessories used for reprocessing.The air/water nozzle was wiped/brushed with a gauze, brush, or sponge.

• 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: 16219637
• MDR Text Key: 309303464
• Report Number: 3002808148-2023-00646
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• 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: 12/22/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2013
• 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
• Treatment: CLV-290SL; CV-290