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

Model Number BML-V442QR-30

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Unspecified Hepatic or Biliary Problem (4493)

Event Date 04/02/2024

Event Type  Death  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This medwatch is related to patient identifier (b)(6).

Event Description

It was reported, the patient underwent a therapeutic endoscopic retrograde cholangiopancreatography (ercp) for gallstone removal, and a significant stone 13x20 was detected in the common bile duct.The stone was captured in a mechanical lithotripter basket inserted into an olympus v system stone crusher.When breaking the stone, the wire broke at the handle, not at the preformed part of the basket.Thus, the wire and stone were stuck at the exit of the bile duct.The wire was then clamped into the emergency lithotripter, but it was still not possible to break the stone and the wire broke again at the handle, not the basket.The device was removed and the patient was taken to urgent surgery due to the device malfunction.The operation was performed that afternoon, but the patient died at dawn the next day.The physician did not see a connection between the death and the device failure, but the failure is what started the chain of events.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19203697
• MDR Text Key: 341298989
• Report Number: 9614641-2024-01009
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BML-V442QR-30
• Device Lot Number: 21K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• 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: OLYMPUS V SYSTEM MAJ-441; SINGLE USE GUIDEWIRE, PAPILLOTOME
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male