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

Model Number BML-V437QR-30

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

E1/establishment name: (b)(6), organization for the promotion of regional medical functions, independent administrative institution added here due to character limitation in respective field.The device was returned and the evaluation found the basket wire had broken at the joint between the operating pipe and the wire.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the single use mechanical lithotripter became incarcerated during the therapeutic endoscopic retrograde cholangiopancreatography (ercp) lithotripsy procedure.The hand part was broken.Although a vanbeck handle was used, the wire broke inside the sheath and the incarceration could not be released.It was reported that a non-olympus basket was incarcerated first, and then the olympus basket was also incarcerated.The bile duct stone was reported to be very hard.The procedure and the patient's anesthesia/sedation was extended half an hour and the ercp lithotripsy was not completed as the patient was transferred to surgery.After surgery, the cholecystectomy/lithotomy/removal of the foreign body (remaining basket) was completed, and the patient was in the hospital recovering from the surgery.

• 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: 18866566
• MDR Text Key: 337293515
• Report Number: 9614641-2024-00623
• 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,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/08/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: BML-V437QR-30
• Device Lot Number: 38K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2023
• 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: JF-260 EVIS LUCERA DUODENOVIDEOSCOPE; VANBECK HANDLE (UNKNOWN MANUFACTURER)
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian