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

Model Number BML-V437QR-30

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

Patient Problems Hypoxia (1918); Perforation (2001); Pancreatitis (4481)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Olympus reviewed the following literature titled, "balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography for the treatment of common bile duct stones in patients with roux-en-y gastrectomy: outcomes and factors affecting complete stone extraction." this retrospective study investigated the treatment outcomes and potential factors affecting complete stone extraction in 79 patients.The initial success rates of reaching the papilla of vater, biliary cannulation, and biliary intervention, including complete stone extraction or biliary stent placement, were 92%, 81%, and 78%, respectively.The multivariate analysis indicated that the largest cbd diameter = 14 mm (odds ratio (or), 0.04; 95% confidence interval (ci), 0.01¿0.58) and retroflex position (or, 6.43; 95% ci, 1.12¿36.81) were independent predictive factors affecting complete stone extraction achievement.This study concludes that therapeutic sdbe-ercp for cbd stones in a relatively elderly ryg cohort, was effective and safe.Type of adverse events/number of patients mild perforation - 1 patient moderate perforation - 1 patient mild pancreatitis - 1 patient mild hypoxia - 1 patient this was a multi-center retrospective study conducted in three tertiary hospitals.This literature article requires 8 reports.The related patient identifiers are as follows: (b)(6)/pr-v220q/ae, (b)(6)/kd-10q-1/ae, (b)(6)/fg-v425pr/ae, (b)(6)/bml-v437qr-30/ae, (b)(6)/pr-v220q/hypoxia for 83-year-old, (b)(6)/kd-10q-1/hypoxia for 83-year-old, (b)(6)/fg-v425pr/hypoxia for 83-year-old, (b)(6)/bml-v437qr-30/hypoxia for 83-year-old.This medwatch is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

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.This supplemental report includes a correction to g2 to provide information that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: 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: 16127150
• MDR Text Key: 306977972
• Report Number: 9614641-2023-00023
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218415
• UDI-Public: 04953170218415
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

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: BML-V437QR-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
• Initial Date Manufacturer Received: 12/11/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NON-OLYMPUS: ENTEROSCOPE EI-530B OR EI-580BT; NON-OLYMPUS: SPHINCTEROTOME (ROTACUTII)
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 83 YR