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

Model Number	GF-UE160-AL5
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is not yet available for this event.The device is returned and an evaluation completed for it.The manufacture date is not available.Upon inspection and testing, the probe unit pink rubber was observed to have a cut.The cut is affecting the ultrasound image.Additionally, there was a cut on the rubber insulation at the distal end and a cut on the light guide tube; both cuts were causing a leak.Insertion tube had multiple buckles.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
Event or Problem Description
The device was sent in for repair of a hole in the distal tip observed during an unknown procedure.There is no harm or adverse impact to the patient.During inspection for repair, it was noted that the pink rubber of the probe unit was cut.This was affecting the ultrasound image.This medwatch is being submitted for the issue of the cut on the pink rubber of the probe.
Additional 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 3 years since the subject device was manufactured.Based on the results of the investigation, the cause of the cut on the pink rubber of the probe was likely due to an external force applied to the distal end.The specific root cause could not be determined at this time.The following information is stated in the instructions for use which may have prevented the event: "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.
Additional Manufacturer Narrative
Additional information has been received from the customer.This supplemental report is being submitted to provide this information.Please see the updates in sections: g3, g6, h2, and h10.There was a hole in the distal end of the device during reprocessing.Per the customer there was wear and tear on the device which possibly caused the hold.Customer then followed protocol to finish the cleaning and sent the device out for repair.

• 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: 12508369
• Report Number: 8010047-2021-12092
• Device Sequence Number: 3598127
• Product Code: ODG
• UDI-Device Identifier: 04953170355349
• UDI-Public: 04953170355349
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2022

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-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 09/22/2021; 01/21/2022
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/08/2021; 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2018
• 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