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

Model Number GF-UCT180

Device Problems Crack (1135); Peeled/Delaminated (1454); 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 of leakage from bending section cover was confirmed.Due to a cut on bending section cover; water tightness was lost.The allegation of leakage from distal end was confirmed.Due to damage on channel tube; water tightness was lost.In addition to evaluation in b5; due to damage on forceps pipe; water tightness was lost.The bending section cover had a cut.The connecting tube had discoloration; due to wear of angle wire.Bending angle in down 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, due to wear of angle wire; the play of right/left knob was out of the standard value, due to wear of forceps wire; the forceps raising angle did not meet the standard value.Grip had a scratch, the universal cord had discoloration, the scope cover had a scratch, the right/left knob was dirty, the up/down knob was dirty, forceps control lever was dirty, the scope connector had a scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus field service engineer reported on behalf of a customer, the evis exera ii ultrasound gastrovidoscope experienced an air/water leakage from bending section cover and suction channel.The event was found during maintenance.There was no report of patient harm.During incoming inspection, the foreign elevator had foreign material; due to insufficient cleaning.The unknown foreign material was yellowish-brown in color.Also, the inside of the light guide lens was dirty and distal end had a crack.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 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 foreign material was insufficient cleaning due to physical damage to the equipment.Identification of the material could not be determined.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: 16737692
• MDR Text Key: 313418549
• Report Number: 3002808148-2023-03694
• 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: Biomedical Engineer
• 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: 04/13/2023
• 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: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2021
• 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