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
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number- (b)(4).This report is related to the following linked patient identifiers: (b)(6); (b)(6); (b)(6).Attempts were performed to obtain additional information, but no response was received.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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 409 patients treated over 16 months, 321 (78.5%) had no tapered bile duct or stone-duct mismatch, and single-session ductal clearance was achieved using standard techniques in 99.7% over median duration of 14 min (interquartile range [iqr] 9-21 min).Of 88 (21.5%) patients with difficult cbds, tapered duct was seen in 79 (89.8%) and/or stone-duct mismatch in 36 (40.9%).Single-session ductal clearance was achieved in all 88 patients (100%) by lbs in 79 (89.8%), mechanical lithotripsy in 20 (22.7%), and single-operator cholangioscopy-guided lithotripsy in 16 (18.2%) over a median duration of 29 min (iqr 17-47 min).Overall, single-session ductal clearance was achieved in 99.8% with adverse events in 17 (4.2%) that included perforation in two, postsphincterotomy bleeding in one, and mild/moderate post-ercp pancreatitis in 14 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=2); 2.Post sphincterotomy bleeding(n=1); 3.Mild/moderate post-ercp pancreatitis(n=14).One 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 two 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 six and three patients, respectively, who were managed conservatively.
Additional 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 reported event was likely an accident, or a complication associated with a surgical procedure while using the subject device.There was no complaint reported on the subject device and 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: 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
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20347685
• Report Number: 9614641-2024-01908
• Device Sequence Number: 18116697
• Product Code: LQC
• UDI-Device Identifier: 04953170218361
• UDI-Public: 04953170218361
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: CLASS2EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Unknown