MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., 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 Date 11/08/2022

Event Type  malfunction  

Event Description

An olympus field service officer reported on behalf of the customer, the evis exera ii ultrasound gastrovideoscope experienced low angulation and free play in up/down knob during maintenance.There was no report of patient harm associated with this event.During incoming inspection, the forceps elevator had foreign material this medwatch is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed, due to wear of angle wire bending angle in up/down and right/left directions did not meet the standard value.In addition to the finds reported in the event section, adhesive on bending section cover was detached.Due to wear of forceps elevator wire, the forceps raising angle did not meet the standard value.Due to clogging of nozzle, water removal ability did not meet the standard value.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Manufacturer Narrative

Updated field: b5, h6 and h10 corrected fields: b5, h6 component code this report is being supplemented to provide additional information based on the device evaluation.

Event Description

Additional information was provided regarding this event.The event occurred during reprocessing.There was no procedure or patient involvement.The staff are trained per the instructions for use and perform cleaning/disinfectant/sterilization steps accordingly.The use of maj-1534 brush for the forceps elevator and scope.

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 could not be determined.It was confirmed, that foreign material was found in the forceps elevator.However, the specific material could not be identified.And the cause as to why it remained in the device could not be specified.The event can be prevented, by following the instructions for use (ifu), which state: "failure to properly clean and high-level disinfect or sterilize endoscope equipment after each procedure can compromise patient safety.To minimize the risk of transmitting infectious agents from one patient to another, after each procedure.The endoscope and the equipment must undergo thorough manual cleaning.Followed by high-level disinfection or sterilization, as described in chapter 7, ¿cleaning, disinfection, and sterilization procedures¿.Reprocess not only the external surface of the endoscope, but also all channels.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.After thoroughly brushing or wiping all external surfaces and the distal end of the endoscope and around the forceps elevator with a soft brush or lint-free cloth.Always visually confirm, that the elevator wire is not broken.If the elevator wire is broken, patient and/or operator injury could result.If the endoscope is not cleaned meticulously, effective disinfection or sterilization may not be possible.Clean the endoscope and accessories thoroughly before disinfection or sterilization to remove microorganisms and organic material that could reduce the efficacy of disinfection or sterilization".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: 16112053
• MDR Text Key: 308447862
• Report Number: 3002808148-2023-00146
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2023

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: 12/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 01/20/2023; 03/04/2023
• Supplement Dates FDA Received: 02/09/2023; 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2019
• 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