MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE MECHANICAL LITHOTRIPTOR V

Model Number	BML-V232QR-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Pneumonia (2011); Septic Shock (2068); Pancreatitis (4481)
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled " orlando protocol for single session ductal clearance of common bile duct stones at endoscopic retrograde cholangiopancreatography ".Objectives: approach to management of common bile duct stones (cbds) by endoscopic retrograde cholangiopancreatography (ercp) is not standardized.We examined outcomes by applying predetermined protocol for cbds management.Methods: when standard extraction techniques failed at ercp, presence of tapered bile duct and stone-duct ratio were calculated.Large balloon sphincteroplasty (lbs) and/or mechanical/single-operator cholangioscopy-guided lithotripsy was performed based on presence of tapered bile duct and stone-duct mismatch.Primary outcome was single-session ductal clearance.Secondary outcome was adverse events.Results: of (b)(4) patients treated over 16 months, (b)(4) ((b)(4)) had no tapered bile duct or stone-duct mismatch, and single-session ductal clearance was achieved using standard techniques in (b)(4) over median duration of 14 min (interquartile range [iqr] 9-21 min).Of (b)(4) patients with difficult cbds, tapered duct was seen in (b)(4) and/or stone-duct mismatch in (b)(4)).Single-session ductal clearance was achieved in all (b)(4) by lbs in (b)(4), mechanical lithotripsy in (b)(4), and single-operator cholangioscopy-guided lithotripsy in (b)(4) over a median duration of 29 min (iqr 17-47 min).Overall, single-session ductal clearance was achieved in (b)(4) with adverse events in (b)(4) that included perforation in (b)(4), postsphincterotomy bleeding in one, and mild/moderate post-ercp pancreatitis in (b)(4) patients.Conclusions: a predetermined protocol optimized outcomes by enabling single-session ductal clearance of cbds with high technical success and low adverse events.¿type of adverse events/number of patients.1.Perforation(n=(b)(4)).2.Post sphincterotomy bleeding(n=(b)(4)).3.Mild/moderate post-ercp pancreatitis(n=(b)(4)).(b)(4) patient with duodenal perforation was successfully treated with placement of an over-the-scope clip, which sealed the perforation and confirmed on fluoroscopy.During hospitalization post procedure, the patient aspirated clear liquids, developed aspiration pneumonia, and subsequently had a cardiopulmonary arrest.Supportive care from this patient was withdrawn 7 days after intervention.Admission was needed post-procedure to the treating facility because of acute pancreatitis, perforation, abdominal pain, bleeding.Duodenal perforation was encountered in (b)(4) patients during duodenoscope navigation that were managed endoscopically using over-the-scope clips.A stent was placed in one patient who underwent a successful second ercp for stone extraction.Mild and moderate pancreatitis were encountered in (b)(4) patients, respectively, who were managed conservatively.This report is related to the following linked patient identifiers: (b)(6).

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Common Device Name: SINGLE USE MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 20347777
• Report Number: 2429304-2024-0000429
• Device Sequence Number: 7931410
• Product Code: LQC
• UDI-Device Identifier: 04953170218361
• UDI-Public: 04953170218361
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2024
• Report Date (Section F): 09/02/2024

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: BML-V232QR-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/02/2024
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2024
• 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: EXTRACTION BALLOON V, MODEL- B-V232P-A, SN-UNK.
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown