MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. CANNULA

Model Number	PR-110Q-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cholangitis (4821)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to olympus for evaluation.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.This report is related to the following linked patient identifiers: (b)(6).
Event or Problem Description
Olympus reviewed the following literature titled "comparative study of therapeutic outcomes in patients who developed hepatolithiasis after hepaticojejunostomy: balloon-assisted enteroscopic approach versus percutaneous transhepatic approach." background: the treatment of hepatolithiasis in patients who underwent hepaticojejunostomy (hjs) is challenging.In this study, we aimed to clarify the therapeutic outcomes of double balloon enteroscopy (dbe) and percutaneous transhepatic biliary drainage (ptbd) for hepatolithiasis after hjs.Methods: patients who underwent dbe or ptbd for hepatolithiasis after hjs at hiroshima university hospital were enrolled, and treatment outcomes and recurrence were compared.Results: forty-eight of the 84 eligible patients underwent dbe, with the hjs site reached in 42 patients (87.5%; dbe group).Forty-one patients underwent ptbd (ptbd group).There were no differences in the clinical characteristics and stone-related factors, including localization, maximum diameter, and quantity, between both groups.The complete stone removal rates in the dbe and ptbd groups were 85.7% and 90.2%, respectively.The dbe group had a significantly shorter median length of hospital stay than the ptbd group (6 vs.21 days, p < 0.001).During a median follow-up of 45 months, stone recurrence was observed in 22 (32.8%) patients.The cumulative recurrence rates at 1, 3, 5, and 10 years were 13.1%, 31.8%, 34.9%, and 52.7%, respectively.The stone recurrence rates of the dbe and ptbd groups were not significantly different (28.6% vs.37.5%).Multivariate analysis revealed a stone diameter > 8 mm (hazard ratio, 2.602; p = 0.026) and age = 70 years (hazard ratio, 3.077; p = 0.017) as independent risk factors for stone recurrence.Conclusions: dbe showed outcomes comparable to those of ptbd in the treatment of hepatolithiasis in patients who underwent hjs.Although reaching the hjs site is difficult in some cases, treatment can be completed within a short period with dbe; therefore, it could be the first choice of treatment for hepatolithiasis after hjs.Type of adverse events/number of patients mild acute cholangitis requiring antibiotic treatment = 6 patients (dbe group), mild acute cholangitis requiring antibiotic treatment = 12 patients (ptbd group).

• Brand Name: CANNULA
• Common Device Name: CANNULA
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21303669
• Report Number: 9614641-2025-00109
• Device Sequence Number: 8876496
• Product Code: ODD
• UDI-Device Identifier: 04953170043765
• UDI-Public: 04953170043765
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K950729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2025

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
• Operator of Device: Health Professional
• Device Model Number: PR-110Q-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .025 INCH GUIDEWIRE; 6-10 MM BALLOON DILATION CATHETER; BASKET CATHETER; ELECTROHYDRAULIC LITHOTRIPSY SYSTEM; ENDOSCOPE; ENDOSCOPIC NASOBILIARY DRAINAGE CATHETER; MECHANICAL LITHOTRIPTER; RETRIEVAL BALLOON CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown