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

Model Number GF-UCT180

Device Problems Crack (1135); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been returned to olympus for evaluation.Preliminary findings.The investigation is ongoing.Physical evaluation of the returned device shows: the date of last inspection/repair is 18apr2018.The device has a total of 1344 uses.The user's report of perforated working channel is confirmed.There is a gap in the adhesive at the distal end.The acoustic lens is cut and damaged.The distal end of the biopsy channel is perforated.The scope connector is loose.There is a defect in the rubber cement.The connecting tube is cut/incised/scratched.The scope body is damaged/discolored.The mouth piece is corroded.There is peeling paint and corrosion in various areas of the scope.The probe unit element/lens cover is scratched/defective.This report will be updated upon completion of the investigation or receipt of additional relevant information.

Event Description

The customer reports during an unspecified procedure using an evis exera ii ultrasound gastrovideoscope, the working channel was perforated when using an xrf probe.The procedure was successfully completed with the same device.There was no harm to the patient.

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 legal manufacturer's investigation, multiple scratches were found at the distal end, and it is seemingly due to external force applied to it.However, the cause of it could not be identified.It was also reported that stain could enter the interior of the lens through the gap.This was caused by the adhesive that was peeled off or was cracked likely due to a shock caused by dropping and knocking the endoscope to a hard surface or object.The instruction manual identifies the following related verbiage that may help prevent the indicated phenomena: ¿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.¿ 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): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12962635
• MDR Text Key: 285612540
• Report Number: 8010047-2021-15765
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170287879
• UDI-Public: 04953170287879
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 02/14/2022

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: 11/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 01/26/2022
• Supplement Dates FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2013
• 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
• Treatment: XRF PROBE