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

Model Number GF-UCT180

Device Problems Material Separation (1562); Failure to Clean Adequately (4048)

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

Event Date 01/02/2024

Event Type  malfunction  

Event Description

The customer reported to olympus, that there was a flushing connection leaking problem on the ultrasound gastrovideoscope.There were no reports of patient harm.The device was returned and evaluated; foreign material was clogged in the air/water channel and nozzle.In addition, there was a gap between the acoustic lens and ultrasound probe.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned and evaluated.In addition to the malfunction documented in b5, the additional evaluation findings are as follows: air/water cylinder and suction cylinder had discoloration; the acoustic lens was damaged; distal end and connecting tube had a scratch; adhesive on bending section cover had a crack, and universal cord had coating peeling.Due to a pinhole on channel tube, water tightness was lost.Due to clogging of air/water tube, no water was fed.Due to wear of forceps elevator lever, the up/down knob cannot be locked securely.Due to deformation of suction connector, water tightness was lost.Due to damage on ultrasonic probe, the number of missing element exceeds the standard value.Due to damage on acoustic lens, the displayed image was defective.Due to wear of angle wire, the bending angle in up direction does not meet the standard value.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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, it is likely that in phenomenon 1 "foreign matter cannot be removed" there is a possibility that the facility could not complete reprocessing before they sent the device to olympus and foreign material remained due to occurrence of leakage.Additionally, with phenomenon 2 "there is a gap between the acoustic lens and the ultrasound probe" it is likely that it occurred due to a handling mistake at the facility, or wear/damage associated with increasing of used time.The event can be detected/prevented by following the instructions for use which state: the reprocessing method is described in the following items.This may prevent the phenomenon: chapter 6 compatible reprocessing methods and chemical agents.Chapter 7 cleaning, disinfection, and sterilization procedures.In addition, regarding the handling of the actual product, the following description is found when the contents of the instruction manual are checked.Thereby, there is a possibility that phenomenon (2) can be prevented."do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient".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: 18535626
• MDR Text Key: 333507242
• Report Number: 3002808148-2024-00552
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2020
• 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