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 returned to the service center for evaluation.The customer¿s complaint of ¿ultrasound cable is leaking¿ was confirmed.Further inspection found a buckle on the insertion tube, a rainbow image, and the scope¿s angulation below standard.Since no repair approval was obtained from the customer the unit was returned unrepaired.The instruction manual states ¿ do not twist or bend the bending section with your hands.Equipment damage may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water.¿ this mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.Investigation activities are ongoing to manage the actions related to this issue and any required mdr reporting.
Event or Problem Description
The service center was informed that during reprocessing, a tear and a leak were noted on the scope¿s bending section.There was no patient involvement reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the lm investigation.Additional information received from the user facility¿s nurse manager states that the event was noticed prior to reprocessing that there was a leak/tear on the bending section of the scope.A leak test is being performed after each use of the device.An mu-1 leak tester is being used.The serial number was unable to be provided.It is unknown how the device became torn/damaged.No metal was protruding.There was no visual deformation such as kinks or buckles noted on the bending section of the scope.The device was reprocessed by manual disinfection.The device is stored horizontal.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reported that the most probable cause for the reported event is as follows: we assume the following.Since some external force was applied to the acoustic lens, the acoustic lens might have been damaged, resulting in scratches (shavings).< genetic mechanisms> the damage to the acoustic lens suggests that some external force was applied.The actual product was manufactured on february 25, 2008, about 12 years and 10 months later, and may have been affected by aging degradation.However, the above is a guess because the actual product is an outgoing product, so the repair history cannot be confirmed.Since the actual product was not sent and cannot be checked, root cause could not be ascertained.There is no generation of this phenomenon caused by products and manufacturing, and there is no problem in the safety.The legal manufacturer confirmed the description of the event in the ifu>3.2 inspection of the endoscope 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. it is not carried out because the product has not been returned yet.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.It was confirmed that there was no unevenness.

• 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: 11126732
• Report Number: 8010047-2021-00963
• Device Sequence Number: 642597
• Product Code: ODG
• UDI-Device Identifier: 04953170203107
• UDI-Public: 04953170203107
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K051541
• Number of Events Summarized: 1
• Summary Report (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): 02/02/2021

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: 10/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1