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 Problem Pancreatitis (4481)

Event Date 11/12/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "addition of mechanical lithotripsy to endoscopic papillary large balloon dilation in patients with difficult common bile duct stones: a retrospective single-center study."     ¿literature summary¿ this retrospective study aimed to compare the treatment outcomes of endoscopic papillary large-balloon dilation (eplbd) with and without mechanical lithotripsy (ml) in removing difficult common bile duct stones.A total of 122 patients were included (n = 44, eplbd + ml and n = 78, eplbd).Compared with the eplbd group, the eplbd + ml group required more endoscopic retrograde cholangiopancreatography (ercp) procedures (¿2) (86% versus 67%) and longer total ercp time after reaching the papilla (78.5 minutes versus 25 minutes).Methods: patients with difficult common bile duct stones treated with eplbd, with or without ml, at the (b)(6) center between (b)(6) 2014 and (b)(6) 2020, were retrospectively evaluated.The rates of cumulative recurrence and complications were compared between the two groups.Results: overall, 122 patients (n = 44, eplbd + ml and n = 78, eplbd) treated by 12 gastroenterologists were included.Patients in the eplbd + ml group were older (85 years versus 81.5 years) and had larger maximum stone diameter (15 mm versus 12.5 mm) than those in the eplbd group.Compared with the eplbd group, the eplbd + ml group required more endoscopic retrograde cholangiopancreatography (ercp) procedures (¿2) (86% versus 67%) and longer total ercp time after reaching the papilla (78.5 minutes versus 25 minutes).Complication rates were not significantly different (9.1% versus 12.8%); however, the cumulative recurrence rates were higher in the eplbd + ml group than in the eplbd group (69.4% versus 23.5% at 4 years).Conclusion: although there were no differences in complication rates, the long-term recurrence rate was higher in the eplbd + ml group than in the eplbd group.This study emphasizes the added burden imposed by performing ml during ercp and suggests that by appropriate case selection, it is possible to treat cases of difficult biliary stones using eplbd without ml.  ¿type of adverse events/number of patients¿ event1: pancreatitis (eplbd + ml group) 3 cases event2: cholangitis (eplbd + ml group) 1 case event3: pancreatitis (eplbd group) 4 cases event4: cholangitis (eplbd group) 6 cases.

Manufacturer Narrative

The literature described mechanical lithotripter, hence olympus selected bml-v437qr-30 as representative model.This report is related to the following linked patient identifiers.(b)(6).Once the investigation has been completed, a supplemental report will be submitted with the device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out (b3).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 events 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.

• 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: 18743701
• MDR Text Key: 335813779
• Report Number: 9614641-2024-00423
• Device Sequence Number: 1
• Product Code: LQC
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BML-V437QR-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2024
• 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: DUODENOSCOPE : TJF-260V, SN -UNK; STONE RETRIEVAL BASKET : FG-V435P, SN- UNK; VISIGLIDE 2 GUIDEWIRE : G-260-3545A, SN -UNK
• Patient Outcome(s): Other