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

Model Number GF-UCT180

Device Problem Failure to Clean Adequately (4048)

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

Event Date 01/10/2024

Event Type  malfunction  

Event Description

It was observed that during the device evaluation the gastrovideoscope had a clogged nozzle.There were no reports of patient harm.

Manufacturer Narrative

The device was returned and evaluated.Evaluation found that the air/water's flow was insufficient due to nozzle was clogged.Additional findings includes; there was a leak from the elevator channel plug.Adhesive was missing around the forceps cover.There were scratches and a chip on the pink probe.There were scratches and a dent on the distal end body.Glue was cracked on the bending section cover.Cement was peeling on the light guide lens.There were broken elements on the ultrasound image.There were minor surface scratches on the insertion tube and light guide tube.There was play on the control knob.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

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.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon of "nozzle is clogged" was confirmed; however, it could not be further identified.There was no information available to determine if reprocessing steps may have been a factor.Therefore, a further cause could not be presumed.The suggested phenomenon of "adhesive around the forceps cover is missing" could not be further presumed from the information obtained in this investigation.As a result of confirming the contents of the instruction manual about shipping products, we found the detailed explanation about reprocessing below: chapter 7 cleaning, disinfection, and sterilization procedures; chapter 8 reprocessing workflow for endoscopes and accessories; chapter 9 reprocessing the endoscope(and related reprocessing accessories).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: 18603198
• MDR Text Key: 334075096
• Report Number: 3002808148-2024-00885
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

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: 01/18/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0500-2021
• Patient Sequence Number: 1