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 from the electrical connector was due to deformation which caused a loss in water tightness.During further inspection, it was observed that the forceps elevator contained foreign material.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 right-left and 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.Lastly, it was observed that the displayed ultrasound image was defective with missing elements due to damage on the ultrasonic cable and acoustic lens.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 electrical connector, specifically in between the scope connector and the water resistance cap.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

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 likely cause of the reported event is due to insufficient or inadequate reprocessing.However, the root cause of the reported event is unable to be determined.The event can be prevented by following the instructions for use (ifu) which state: important information ¿ please read before use.Caution: ¿after using the endoscope reprocess it according to the instructions given in chapter 7, "cleaning, disinfection, and sterilization procedures".Using improperly or incompletely reprocessed, the endoscope's distal end damage may result.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.¿ important information ¿ please read before use.Warnings and cautions-caution: do not coil the insertion tube or universal cord with a diameter of less than 12 cm.Equipment damage can result.Do not attempt to bend the endoscope's insertion section with excessive force.Otherwise, the insertion section may be damaged.Do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end.Visual abnormalities may result.Do not twist or bend the bending section with your hands.Equipment damage may result.The endoscope's remote switches cannot be removed from the control section.Pressing, pulling, or twisting them with excessive force can break the switches and/or cause water leaks.To prevent unnecessary patient exposure to ultrasound radiation, follow the 'as-low-as-reasonably achievable' (alara) principle when using ultrasound equipment.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: 15608075
• MDR Text Key: 307180756
• Report Number: 3002808148-2022-03181
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

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
• 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: 11/18/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2016
• 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