MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE DISTAL COVER

Model Number	MAJ-2315
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	03/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to an olympus endoscopy account manager that a patient had an endoscopic retrograde cholangiopancreatography (ercp) using an evis exera iii duodenovideoscope (tjf-q190v) with disposable cap (subject device, maj-2315).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 patient's current condition was described as recovered fully, discharged home, with a planned ercp to remove the bile duct stent which was placed, probably in mid to late (b)(6) 2021.Additional information was later provided by the customer: the customer was unaware of the scope ¿malfunctioning.¿ the disposable cap used in the procedure was not available for evaluation, it was discarded after the procedure.Operative reports were 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.This report is for the maj-2315 (single use distal cover).This report is related to complaint number (b)(4), which was reported for the tjf-q190v scope under mdr number 2951238-2021-00314.

• Brand Name: SINGLE USE DISTAL COVER
• Common Device Name: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• MDR Report Key: 16345232
• Report Number: 2429304-2023-00021
• Device Sequence Number: 19220360
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/09/2023
• 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: MAJ-2315
• Device Lot Number: UNKNOWN
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2023
• 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: OLYMPUS GIF-H190 S/N (B)(4).; OLYMPUS TJF-Q190V S/N (B)(4).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Race: White