MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GASTROVIDEOSCOPE

Model Number	GF-UC140P-AL5
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by olympus.The evaluation found that the scope was insufficiently or incorrectly reprocessed and the scope was used for next procedure, as evidenced by the presence of cleaning solution on the insertion section or distal end.Additional evaluation findings are as follows: air/water leakage from insertion section.Universal cord defects.Angulation malfunction.Ultrasound probe defects.5.) defects of the insertion tube.Distal end defects.The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
A user facility returned the olympus, model gf-uc140p-al5, ultrasonic gastrovideoscope to olympus for repair due to a report of "distal end leak." upon inspection and testing of the returned device, it was determined that the scope was insufficiently or incorrectly reprocessed and the scope was used for next procedure.This report is submitted due to the scope was insufficiently or incorrectly reprocessed and the scope was used for next procedure.There was no patient injury, associated with the problem, reported to olympus.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and customer follow-up.Event: updated with additional information received from the customer.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.The device met all specifications at the time of shipment.Based on the results of the investigation, the event may be caused by insufficiently reprocessing, physical and chemical stress, mishandling of the device, and cracks and abrasion.However, the specific root cause could not be determined at this time.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Customer confirmed the event occurred after a procedure during leak testing and cleaning.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Common Device Name: ULTRASONIC 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: 14403028
• Report Number: 8010047-2022-08251
• Device Sequence Number: 5500203
• Product Code: ODG
• UDI-Device Identifier: 04953170062803
• UDI-Public: 04953170062803
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K011314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: GF-UC140P-AL5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 05/14/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown