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

Model Number BML-V232QR-26

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

Patient Problem Injury (2348)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

As a result of the actual product analysis, the basket wire was broken at three places.(a.Position of about 90 mm from the distal end of the basket, b.Approximately 935 mm from the distal end of the basket, c.Operation pipe rod connection part) the operation pipe part was not returned.Considering the length of the returned basket wire, omsc was able to judge that anything other than the operation pipe was sent without any damage.Fracture surface at the position of about 90 mm from the basket tip was cut with a tool.Also, the fracture surface about 935 mm from the basket tip was stretched implying ductile fracture.Furthermore, the basket wire was deformed.There was no abnormality in the bonded state of the joint portion of the operation pipe.From dhr of the same lot for the subject device, nothing abnormal related to the reported event was detected on the following items.Outer diameter of the basket wire; deformation of the basket wire; outer diameter of the operating wire; overflown length of the brazing filler at the brazed part; outer diameter of the brazing part; outer appearance of the brazing part.Based on the state of the actual device and the situation at the time of occurrence, it is presumed that the operation wire and the holder have stopped moving according to the following mechanism.At the time of crushing, a large force exceeding the strength of the product was added due to factors such as size, hardness and shape of calculus; due to a load greater than the strength limit, deformation of the basket, buckling of the coil sheath and fracture at the operation pipe section occurred; even in crushing stone using bml-110a-1, the basket wire broke because a large force exceeding the strength of the product was added due to factors such as size, hardness and shape of calculus.As described in the instruction manual, this device is not designed to be capable of crushing all calculus.Consequently, the pipe or basket wire may break and part of the lithotriptor may remain in the body.If the basket of the lithotriptor would be continuously retracted until it breaks, the fracture mode depends on shapes of the calculus, bending condition of the coil sheath and the other condition.Therefore, the lithotriptor does not always break at the same part.It is a property of the lithotriptor.If repeating lithotripsy is required in a single procedure, make sure to check that no abnormality is found in operation and/or appearance (e.G.Cut or worn of the basket wire, notable coil sheath bent or gap etc.) every time of crashing colliculus.Stop use when any abnormality is detected.Warning: a lithotriptor cannot always crush all calculi captured in the basket.Operation of this instrument is based on the assumption that open surgery is possible as an emergency measure.If the calculus is too hard, it is possible that the damages shown in chapter 5, "emergency treatment" may occur.Use the lithotriptor by considering that it may lead to damaging the instrument and that open surgery may have to take place; do not use this lithotriptor bml-110a-1 for a calculus that is assumed impossible to be crushed by this ithotriptor.The basket wire etc.May break and part of this lithotriptor may remain in the body; use this instrument by having the settings to switch to open surgery and the hospitalization plan ready in case the calculus cannot be crushed by lithotriptor bml-110a-1; the operation of the mechanical lithotriptor bml-110a-1 is based on the assumption that open surgery is possible as an emergency measure.If the calculus is too hard and the basket wire or mechanical lithotriptor is damaged, lithotripsy cannot be continued.Use the bml-110a-1 with the understanding that its basket wire could become damaged and that open surgery may have to take place.

Event Description

On (b)(6) 2016, during a biliary lithotripsy using the subject device, crashing a calculus 12mm in size was performed, but the device was impacted with calculus in the bile duct because the calculus was too hard.Bml-110a-1 was used to release the impaction.The operation wire of the subject device broke when rotation of the bar of the mechanical lithotripter started.The doctor switched to open surgery while the calculus and the basket of the subject device were remained in bile duct.The calculus and the remained operation wire were retrieved.The patient was hospitalized in a general ward of the facility.On (b)(6) 2016, the patient stays in hospital without any problem.There has not been any adverse event report about bml-110a-1.

• Brand Name: OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORP.; 2951; ishikawa-cho,; hachioji-shi, tokyo 192-8 502; JA 192-8502
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6146654
• MDR Text Key: 61492554
• Report Number: 8010047-2016-01551
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2016

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: Physician
• Device Model Number: BML-V232QR-26
• Device Lot Number: K6711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2016
• 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): Other
• Patient Age: 63 YR