MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problem Residue After Decontamination (2325)

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

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been evaluated by olympus.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.Physical evaluation of the complaint device reveals: the device passed the dunk test.There is cracking in the rubber glue.There is residue under the forceps lever.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

During evaluation of an evis exera ii ultrasound gastrovideoscope, it was found to have residue under the forceps lever.There was no patient impact related to this occurrence.

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, it is likely the foreign matter could not be completely cleaned and remained because the cleaning at the facility after the previous case was insufficient.In addition, black foreign matter is considered to be the adhesive applied when assembling the equipment.It is presumed that this adhesive was peeled off due to excessive external force applied during reprocessing.The instruction manual for this product describes the reprocessing method around the forceps table, chapter 7 cleaning, disinfection, and sterilization procedures: "brushing around the forceps elevator and instrument channel outlet.Flushing the interior of the forceps elevator." the event can be prevented by performing the reprocess according to the instruction manual.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11373649
• MDR Text Key: 233343652
• Report Number: 8010047-2021-02961
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170355479
• UDI-Public: 04953170355479
• Combination Product (y/n): N
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• 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: 02/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1