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

Model Number MAJ-2315

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 03/14/2021

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 309372217
• Report Number: 2429304-2023-00021
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/17/2021,02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS GIF-H190 S/N (B)(4).; OLYMPUS TJF-Q190V S/N (B)(4).
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Race: White