MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE

Model Number	TJF-Q190V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Adult Respiratory Distress Syndrome (1696)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that unbeknownst to the health care provider, the single use distal cover had apparently come off of the evis exera iii duodenovideoscope and into the patient's throat after an endoscopic retrograde pancreatography (ercp) procedure, which caused the patient to go into respiratory distress in the post anesthesia care unit (pacu).The distal cover was suctioned out from the patient's throat and the patient's respiratory status went back to normal.The procedure took about 1 hour and had been completed using the same device without delay.The outcome of the procedure was not impacted.The customer indicated that the scope was functioning properly and that an olympus representative had advised that the distal cover came off probably due to not being put on correctly.An inservice was pending on how to properly put on the distal cover.This event is reported under the following related patient identifiers: (b)(6) evis exera iii duodenovideoscope.(b)(6) single use distal cover.This medwatch is for patient identifier (b)(6).E1: adventist health system sunbelt inc florida hospital warehouse (documented here in its entirety due to character limitations in respective field).

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 17646116
• Report Number: 2429304-2023-00273
• Device Sequence Number: 7458812
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/29/2023
• Report Date (Section F): 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MAJ-2315 - SINGLE USE DISTAL COVER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown