MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ENDOSCOPIC CO2 REGULATION UNIT

Model Number UCR

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

Patient Problem Perforation (2001)

Event Date 02/13/2023

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled, "clinical outcomes of eus-guided choledochoduodenostomy for biliary drainage in unresectable pancreatic cancer: a case series" introduction.Pancreatic ductal adenocarcinoma (pda) is associated with poor prognosis and 98% loss-of-life expectancy.80% of patients with pda are unfit for radical surgery.In those cases, emphasis is set on management of cancer-related symptoms, among which obstructive jaundice is most common.Endoscopic ultrasound-guided biliary drainage (eus-bd) emerges as a valid alternative to the well-accepted methods for treatment of biliary obstruction.Patient selection.Five consecutive patients with unresectable pancreatic malignancy, were subjected to eus-bd, particularly eus-guided choledochoduodenostomy (eus-cds).Ethics.Oral and written informed consent was obtained in all cases prior procedure.Technique.Eus-guided puncture of the common bile duct was performed, followed by advancement of a guidewire to the intrahepatic bile ducts.After dilation of the fistulous tract with a cystotome, a fully covered self-expandable metal stent was inserted below the hepatic confluence and extending at least 3 cm in the duodenum.Technical and clinical success was achieved in four patients without adverse events.In one patient procedure failed due to dislocation of the guidewire, with consequent biliary leakage requiring urgent surgery.Recovery was uneventful with no further clinical sequelae and there was no mortality associated with procedure.Discussion.Introduced in 2001, eus-guided biliary drainage has become an accepted option for treatment of obstructive jaundice.According to recent guidelines published by european society of gastrointestinal endoscopy (esge) in 2022, eus-cds is a preferred modality to percutaneous transhepatic biliary drainage (ptbd) and surgery in patients with failed ercp, with comparable efficiency and better safety profile, which is supported by our experience with the procedure.An attempt was made then to dilate the fistula with a 10 fr cystotome and reposition the guidewire, but the large bore cystotome turned out to be too rigid to manipulate.Eventually dislocation of the guidewire occurred during manipulation and further access to the bile ducts was impossible as they were almost entirely decompressed.Ptbd was not technically feasible, so patient was referred for urgent surgery.Conclusions.Our case series suggests that eus-cds is an excellent option for palliative management of malignant distal biliary obstruction, emphasizes on the importance of adequate technique and experience for the technical success, and urges the need for future research on establishing the best choice for guidewire and dilation device.Type of adverse events/number of patients perforation, bile leakage (n=1).This literature article requires 4 reports.The related patient identifiers are as follows: (b)(6) (for gf-uct160-ol5) ,(b)(6) (for ucr), (b)(6) (for gf-uct160-ol5) ,(b)(6) (for ucr).This patient died 4 months after the procedure from causes unrelated to the endoscopic or surgical procedure.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Type of Device: CO2 REGULATION UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16569875
• MDR Text Key: 311563414
• Report Number: 3002808148-2023-02690
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• Combination Product (y/n): N
• Reporter Country Code: BU
• PMA/PMN Number: K081173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: UCR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/18/2023
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NON-OLYMPUS: CYSTOTOME.; NON-OLYMPUS: FNA NEEDLE.; NON-OLYMPUS: GUIDEWIRE.; NON-OLYMPUS: METAL STENT.; NON-OLYMPUS: PULSERA C-ARM.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Female