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

Model Number	GF-UCT180
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The scope was returned to the service center for evaluation.The customer¿s complaint of ¿the balloon did not inflate or insufflate ¿could not be duplicated.The balloon was found inflating and deflating normally with the test olympus equipment.The glue was found missing on the forceps riser holding cover.Deep scratches were notes on the bending section and the bending section glue was found cracked.The cause of the reported event cannot be determined at this time.The investigation is ongoing and if additional information is received this report will be supplemented accordingly.
Event or Problem Description
The service center was informed that the balloon does not inflate and will not insufflate.There was no patient involvement reported.No further information was provided.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer was unable to determine the root cause.Lm reported that the most probable cause for the reported event is as follows: it is assumed that this event occurred when external force was exerted by rubbing or striking the area strongly during transportation, storage, use, cleaning, etc.This event can be prevented by observing the items listed in the instruction manual.Therefore, it is assumed that this event was caused by the user's handling.Warnings and cautions (p.7).Warning "do not strike, hit, or drop the endoscope's distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope's distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.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: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Common Device Name: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11493402
• Report Number: 8010047-2021-03767
• Device Sequence Number: 12099575
• Product Code: ODG
• UDI-Device Identifier: 04953170355462
• UDI-Public: 04953170355462
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K093395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1