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

Model Number	BML-V242QR-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Hepatic or Biliary Problem (4493)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The literature listed "bml-v242qr-302" olympus selected bml-v242qr-30 as the representative devices.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.
Event or Problem Description
Olympus reviewed the following literature titled "outcome of digital cholangioscopy and laser lithotripsy for impacted biliary stones." the aim of this retrospective study is to report the efficacy and safety of intracorporeal laser lithotripsy for impacted stones in the bile duct in the 43 patients.There were 20 (46.51%) patients had single stone, 35(81.39%) patients had only bile duct stones, and 8 (18.61%) patients had additional stones in cystic duct or intrahepatic biliary radical.This study concluded that intracorporeal laser lithotripsy is an effective and safe modality for the clearance of impacted bile duct stones.Type of adverse events/number of patients: cholangitis - 1 patient.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6) (tjf-q180v).(b)(6) (bml-v242qr-30).(b)(6) (fg-v425pr).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.
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 relationship between the device and the adverse event 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.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the attached literature article for additional information.

• 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: 15925221
• Report Number: 9614641-2022-00709
• Device Sequence Number: 6450173
• Product Code: LQC
• UDI-Device Identifier: 14953170218399
• UDI-Public: 04953170218392
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2022

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-V242QR-30
• Device Lot Number: UNKNOWN(LITERATURE)
• 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: 12/06/2022
• Supplement Date Received by Manufacturer: 12/06/2022; 12/08/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 12/06/2022; 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: NON-OLYMPUS, AURIGA, HOLMIUM LASER, SN UNKNOWN; NON-OLYMPUS, CRE, SN UNKNOWN; NON-OLYMPUS, EXTRACTOR PRO XL, SN UNKNOWN; NON-OLYMPUS, SPYSCOPE DS,, SN UNKNOWN; NON-OLYMPUS, ULTRATOME XL, SN UNKNOWN; NON-OLYMPUS, VISIGLIDE, SN UNKNOWN; OLYMPUS FG-V425PR, SN UNKNOWN; OLYMPUS TJF-Q180V, SN UNKNOWN
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown