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 Type  malfunction  

Event Description

The subject device (evis exera ii ultrasound gastrovideoscope) is an olympus loaner asset that was returned to an olympus service center with no alleged complaint.During incoming inspection, foreign material was found on the forceps elevator.This report is being submitted for the foreign material.

Manufacturer Narrative

In addition to the findings reported, the balloon water tube was damaged causing water tightness to be lost.Due to clogging of nozzle, water removal ability did not meet specification.The bending angle in up, down and left direction was insufficient due to the elongation of the angle wire.The play of the up/down angle knob was out of specification due to the elongation of the angle wire.The bending section cover was dirty.The control unit was scratched.The acoustic lens was scratched.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation, or if additional information is received.

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 e3, h6, and h10.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, a definitive root cause could not be determined.However, it is likely due to insufficient cleaning (handling problems).The following information is stated in the instructions for use (ifu): ¿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.¿ 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: 15785851
• MDR Text Key: 307882912
• Report Number: 3002808148-2022-04114
• 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,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: 10/16/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2022
• Initial Date FDA Received: 11/12/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2020
• 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