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

Model Number GF-UCT180

Device Problems Device Reprocessing Problem (1091); 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.Due to damage on channel tube; water tightness was lost.In addition to evaluation in b5, the suction cylinder was shaved.Due to damage to the air/water tube; no water was fed.Due to damage on air/water tube; the amount of water contact did not meet the standard value.Due to wear of angle wire; angle was insufficient.Due to wear of angle wire; play of the knob was out of standard.The adhesive on the bending section cover was detached, connecting tube had a scratch, universal cord had a scratch, the distal end had a scratch, the control unit was dirty, the control unit had a scratch.Due to damage on forceps wire; forceps raising angle did not meet the standard value.The light guide bundle was slipping down.Due to a cut on bending section cover; water tightness was lost.The acoustic lens had a scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus field service officer reported on behalf of a customer, the evis exera ii ultrasound gastrovideoscope experienced leakage from the suction channel.The event occurred during maintenance.There was no report of patient harm.During incoming inspection, a foreign matter yellowish/brown in color was within the forceps elevator, due to insufficient cleaning.Also, the balloon channel was clogged with foreign objects, due to insufficient reprocessing.This medwatch is being submitted to capture the reportable malfunctions 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 root cause of the event was unable to be identified; however, it is likely that the foreign material could not be removed due to physical damage of the device.The event can be detected/prevented by following the instructions for use which state: 1) "do not coil the insertion tube or universal cord with a diameter of less than 12 cm.Equipment damage can result." 2) "do not attempt to bend the endoscope¿s insertion section with excessive force.Otherwise, the insertion section may be damaged." 3) "do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end.Visual abnormalities may result." 4) "do not twist or bend the bending section with your hands.Equipment damage may result." 5) "the endoscope¿s remote switches cannot be removed from the control section.Pressing, pulling, or twisting them with excessive force can break the switches and/or cause water leaks." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 16812355
• MDR Text Key: 314000094
• Report Number: 3002808148-2023-04189
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170341793
• UDI-Public: 04953170341793
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2012
• 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