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

Model Number GF-UCT180

Device Problems 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 device was returned to olympus for evaluation and the customer's allegation was able to be confirmed.During the device evaluation it was observed that the leakage was due to damage to the channel tube and as a result caused a loss in water tightness.During further inspection, it was observed that the forceps elevator contained foreign material due to insufficient cleaning and handling.It was observed that the adhesive on the bending section cover was detached, and the bending section cover itself was discolored.It was also observed that the bending angle in the up, down, left, and right direction did not meet the standard value due to wear of the angle wire.Also, the play knob in the up-down was out of standard value due to wear of the angle wire.Clogging of the nozzle was observed, causing the inability of water removal which did not meet standard.This clogging was due to insufficient reprocessing of the scope.Lastly, it was observed that the suction cylinder was shaved, and the light guide bundle had breakage due to physical stress caused by handling.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The field service engineer (fse) reported to olympus on behalf of the customer, the evis exera ii ultrasound gastrovideoscope had leakage from the biopsy channel.This issue was found during reprocessing.There was no patient/user harm or injury reported due to the event.Upon device return and evaluation it was observed that the forceps elevator contained foreign material, which is a reportable event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

Update: h4, h6, h10.This report is being submitted to provide additional information based on the legal manufacturer¿s final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the observed issue.Based on the results of the investigation, the cause of the foreign body / material is likely due to a lack of cleaning.However, a definitive root cause could not be identified.The occurrence of the issue can be prevented by adhering to the instructions for use (ifu) which states the following: ¿important information ¿ please read before use.Chapter 7 cleaning, disinfection, and sterilization procedures.Warning.·all channels of the endoscope, including the elevator wire channel and balloon channel, must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope".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 CORP. LTD.; 3-1 okamiyama, odakura; nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15608087
• MDR Text Key: 302431394
• Report Number: 3002808148-2022-03182
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

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: 09/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2011
• 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