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); Scratched Material (3020); Failure to Clean Adequately (4048)

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

Event Date 10/14/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was not confirmed.In addition to the finds, due to clogging of nozzle, water removal ability did not meet specification.The bending angle was insufficient due to the elongation of the angle wire.The play of the angle knob was not in specification due to the elongation of the angle wire.Due to wear of angle wire, bending section could not be bent in right direction.Adhesive on bending section cover was detached.Due to a pinhole on bending section cover, water tightness was lost.Connecting tube, universal cord and control unit were scratched.The scope cover was dented.The grip was dented and deformed.Forceps channel port was deformed.Due to a chip on acoustic lens, insulation resistance value did not meet specification.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus field service officer reported on behalf of the customer, the evis exera ii ultrasound gastrovideoscope experienced a leakage through the suction channel.The event occurred during reprocessing.There was no reported of patient harm associated with the event.During incoming inspection, it was determined there was a foreign material in the forceps elevator.Also, the acoustic lens had scratches that extended down to the adhesive layer.This mdr is being submitted to capture the reportable malfunctions found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely the foreign body on the forceps elevator is due to insufficient cleaning and the acoustic lens scratches are likely due to physical stress.The following information is stated in the instructions for use (ifu): ¿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.¿ ¿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.To prevent unnecessary patient exposure to ultrasound radiation, follow the ¿as-low-as-reasonably achievable¿ (alara) principle when using ultrasound equipment.Freeze the image whenever you are not actively viewing the ¿live¿ ultrasound image.When the equipment is in the freeze mode, no ultrasound energy is emitted.¿ 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: 15907126
• MDR Text Key: 307918251
• Report Number: 3002808148-2022-04815
• 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: 02/01/2023

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: 11/03/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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