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

Model Number GF-UCT180

Device Problem Material Separation (1562)

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

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated by olympus.In addition to the findings evaluation found the customer complaint was confirmed and water tightness was lost due to a pin hole in the instrument tube, air/water tube, and bending section rubber.Evaluation also found the expected insulation capacity could not be obtained due to a cut on the heat shrinking tube of the lock engagement lever, forceps control lever did not move smoothly due to damage on the lever mount, the natural position of the angle knob was out of the specified position due to deformation of the up/down knob, the up/down knob cannot be locked securely due to wear of the lock engagement lever, the scope connector cover was cracked, the switch #1 was discolored, the right/left knob was deformed, the control unit was deformed, the paint on the air/water cylinder and suction cylinder was peeled, the bending section rubber was cut, insulation resistance at the distal end did not meet standard value, the acoustic lens was damaged and scratched, the distal end was dented, the adhesive around the light guide lens was worn, the bending section rubber was cut, the connecting tube had a snag and the coating was peeling, the forceps elevator had play due to k-wire wear, the play of the up/down knob and right/left knob was out of standard value due to wear of the angle wire, tightness of the braid was uneven due to deterioration of the bending tube braid, the bending tube was damaged, and the universal cord was scratched.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the distal end of the evis exera ii ultrasound gastrovideoscope was leaking.There was no effect on the patient or user since the issue occurred during pre or post processing.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found there was a gap between the acoustic lens and ultrasound probe and a gap of adhesive on the distal end with a stain entering inside the lens through the gap.The report is being submitted due to the gap between the lens and probe and gap in the adhesive found during evaluation.

Manufacturer Narrative

Update: 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 reported issue.Based on the results of the investigation, the cause of the issue could not be identified.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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15775617
• MDR Text Key: 307768622
• Report Number: 3002808148-2022-04028
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,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

• Date FDA Received: 11/10/2022
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2015
• 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