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

Model Number GF-UCT180

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Event Description

The customer reported to olympus the the ultrasound gastrovideoscope had a working channel at the distal end that was defective.Customer did not specify during what type of device use the issue was observed.The device was returned and during the device evaluation the following reportable malfunction was found: foreign matter clogging the nozzle.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus and evaluated.The customer¿s allegation was not confirmed.In addition to the reportable malfunction of foreign matter in nozzle unit, the evaluation found the following non-reportable malfunction(s): due to wear of forceps elevator lever, up/down (u/d) knob cannot be locked securely.Due to wear of knob wire, forceps do not rise up at all; due to wear of angle wire, bending angle in down direction does not meet the standard value; due to damage on channel tube, forceps cannot be inserted smoothly, peeling of scope cover plate and connecting tube coating, suction cylinder has corrosion, adhesive on a-rubber has a chip.The investigation is ongoing and follow-up with the user facility is currently being performed.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.Three attempts were performed to obtain additional information, but no response was received from the customer.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 could not be removed from the nozzle even though proper reprocessing was conducted due to buckling of each channel/nozzle or gap at insertion section/boot.Additionally, olympus confirmed the forceps elevator did not rise up due to corrosion on forceps elevator wire.A definitive root cause for the device damage could not be identified.The event can be prevented by following the instructions for use which state: "¿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: 18501402
• MDR Text Key: 332728530
• Report Number: 3002808148-2024-00407
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• 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: 03/27/2024

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: 01/05/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• 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