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

Model Number	GF-UE160-AL5
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was return to the service center for evaluation.The customer¿s complaint of a ¿leak ¿ was confirmed.The pink rubber on the scope¿s probe was found to have a deep cut.The bending section rubber was found to have excessive scratches.There were 10 plus broken strands found on the scope¿s bending section.The scope¿s light guide tube was found buckled.The ultrasound image was checked and six broken elements.The scope¿s angulation knob was found to have low tension, play and loose ud.The scopes ¿s id chip showed 815 total uses.The instruction manual section ¿chapter 3 preparation and inspection¿ states ¿before each procedure, prepare and inspect this instrument as instructed below.Inspect other equipment to be used with this instrument as described in their respective instruction manuals.If any irregularities are suspected after inspection, follow the instructions given in chapter 10, ¿troubleshooting¿.If this instrument malfunctions, do not use it.Return it to olympus for repair as described in section 10.3, ¿returning the endoscope for repair.¿ the investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The service center was informed that during unspecified procedure, the scope was leaking and the balloon would not fill.It is unknown if the intended procedure was completed.There was no patient injury reported.
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 (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable cause is likely the amount of use and age of the device (over 10 years) may have led to the peeling of the rubber.Additionally, it it likely that the phenomena occurred due to external force such as strong rubbing on the part in normal use including reprocess.This issue is addressed in the instructions for use (ifu): "inspection of the endoscope 3.Inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, scratching, sagging, deformation, excessive bending, protruding objects or other irregularities.".

• 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
• MDR Report Key: 11131330
• Report Number: 8010047-2021-01021
• Device Sequence Number: 4125038
• Product Code: ODG
• UDI-Device Identifier: 04953170203107
• UDI-Public: 04953170203107
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: 12/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1