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

Model Number	TJF-Q190V
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946); Pain (1994)
Date of Event	03/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported a patient had an endoscopic retrograde cholangiopancreatography (ercp) using an evis exera iii duodenovideoscope with disposable cap.Suction was set at 120mm/hg for this procedure.During this procedure, the doctor noticed bleeding from the patient's mouth after the scope was inserted, the doctor withdrew the tjf-q190v scope, and the procedure was aborted.The patient had to remain intubated after the procedure.The patient was transferred to another hospital for a higher level of care.Five days later, a repeat ercp and esophagogastroduodenoscopy (egd) was performed by a second doctor using the older model scope without disposable tip.During this procedure the doctor saw a 13cm long 2-3mm wide healing laceration extending from her ge junction to the upper mid esophagus.The injury necessitated blood transfusion, prolonged endotracheal intubation following the initial ercp, hospital transfer to a higher level of care, several more days stay as an inpatient, as well as causing significant painful swallowing for 2-3 days.The patients current condition is described as recovered fully, discharged home, with a planned ercp to remove the bile duct stent which was placed, probably in mid to late may.
Event or Problem Description
New information provided by the customer: i am unaware of the scope ¿malfunctioning.¿ the disposable cap used in the procedure is not available for evaluation, it was discarded after the procedure.Operative reports provided with the following information: for the procedure completed (b)(6) 2021: the patient took enoxaparin last one day prior to the procedure.The patient's asa (anesthesia risk score) was iii-patient with severe systemic disease.The diagnostic ercp was aborted due to pyloric stenosis and esophageal mucosal injury resulting from the passage of the duodenoscope with bleeding.The ercp was technically difficult and complex due to excessive bleeding and duodenal stenosis.Evaluation of the duodenoscope revealed the plastic tip in proper position.For the procedure completed (b)(6) 2021, the patient's asa (anesthesia risk score) was iii-patient with severe systemic disease.The patient's pylorus was slightly strictured and required dilation before passing the tjf-180 scope without distal cap.Multiple attempts (over a 30 min period) were required to cannulate the bile duct.A bile leak was visualized at the level of the cystic duct clips.A stent was placed in good position.No further consequences to the patient have been reported.

• 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: 11642030
• Report Number: 2951238-2021-00314
• Device Sequence Number: 1832327
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021
• Report Date (Section F): 03/17/2021

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: 03/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/07/2021
• 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: GIF-H190, SERIAL NUMBER (B)(6)
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 50