MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V

Model Number BML-V232QR-30

Device Problems Difficult to Remove (1528); Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 06/23/2010

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp (omsc) for evaluation.As a result of confirming the subject device, the basket wire was broken at approximately 920 mm from the distal end of the basket.The fracture was stretched implying ductile fracture.The basket wire was deformed.Based on the state of the actual device and the situation at the time of occurrence, it is presumed bellow: at the time of crushing, a large force exceeding the strength of the product was added due to the factors such as size, hardness and shape of calculus, causing the basket wire breakage; the basket wire was deformed because a large force was added at the time of crushing.The following details are found in the instruction manual as warning: this instrument will deform and/or deteriorate by performing lithotripsy.When lithotripsy is repeated, it will deform and/or deteriorate furthermore.By such deformation and/or deterioration, calculus may not be crushed and/or the instrument with calculus engaged may not be removed from the body.If lithotripsy is required to be repeated in a single case, make sure to check each time that no abnormality is found in action and/or appearance (e.G.Basket wire cut or worn, tube sheath bent, notable coil sheath bent or gap, tube sheath not completely retracted in coil sheath etc.).Stop use when any abnormality is detected.

Event Description

Olympus medical systems corporation (omsc) performed a mdr retrospective review and found that this report was required.During a biliary lithotripsy, the operation pipe was broken at the junction with the basket wire because the calculus was too hard.It was attempted to crush the calculus with a bml-110a-1, but the calculus could not be crushed.The broken part of the subject device and the calculus were remained in the patient.The following day, the doctor switched to open surgery and completed the procedure.The broken part was retrieved from the patient.On (b)(6) 2010, the patient's condition recovered.

• Brand Name: OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: kunimori yamaguchi ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6278130
• MDR Text Key: 65764414
• Report Number: 8010047-2017-10067
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/26/2017

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-V232QR-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2010
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2010
• Initial Date FDA Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR