MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III DUODENOVIDEOSCOPE

Model Number	TJF-Q190V
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports, during a decompression endoscopic retrograde cholangiopancreatography (ercp) using an evis exera iii duodenovideoscope with a single use distal cover, and an unspecified esophagogastroduodenoscopy (egd) scope, (there were no issue with the egd scope) the physician saw a lot of bleeding during the procedure and upon removal of the scope, the distal cover was twisted leaving the metal ridge on the distal tip of the scope exposed.There were anatomical challenges encountered during the procedure.The patient's anatomy was described as: extremely j-shaped stomach with the entrance to the pylorus at an unusual angle the bleeding was found to be caused by a 12mm in length laceration to the muscularis found on the greater curvature of the stomach.The physician stopped the bleeding using hemostasis clips and was able to complete the procedure.There was no abnormality in the appearance of the scope or distal cover prior to the initiation of the procedure.The distal cover used in the procedure was discarded and cannot be returned for evaluation.No images an be provided.The patient's current condition is deceased, not related to the laceration, but due to underlying pathology.Case with patient identifier (b)(6) reports the evis exera iii duodenovideoscope used in the procedure.Case with patient identifier (b)(6) reports the single use distal cover used in the procedure.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 13588938
• Report Number: 2951238-2022-00321
• Device Sequence Number: 16192280
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/23/2022
• Report Date (Section F): 01/27/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/27/2022
• Date Report to Manufacturer: 01/27/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2022
• 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 LOT H1203, EGD SCOPE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 55 KG