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

Model Number BML-V437QR-30

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

The subject product was returned to omsc for investigation.The investigation confirmed that the operation pipe was broken at the junction with the basket wire.There were no abnormalities found upon investigation of the condition of solder part and the outer diameter of the junction.When measured, a part of the operation wire was missing 94mm from the junction with the operation pipe.The fracture surface of the operation wire was a sharp edge as if it was cut with a tool.The coil sheath was cut at two places.The coil sheath had a buckling at 50-60mm from the distal end.In addition, the basket was deformed.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.From the conditions of the subject device, it is surmised that during crushing the calculus, a larger load than durability strength of the product was applied due to the factors, such as size, hardness, and shape of the calculus, which caused the buckling of the coil sheath, the breakage at the junction between the operation pipe and the basket wire and the deformation of the basket.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.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 ithotripsy 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

During an endoscopic bile duct calculus exclusion procedure on (b)(6) 2016, the doctor tried to crush a calculus with the subject device, but it was broken at the junction between the operation pipe and the operation wire.The doctor removed the subject device from the patient and replaced it with another device, and then completed crushing the calculus without problems.There was no patient injury reported.

• 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: 6119622
• MDR Text Key: 60655769
• Report Number: 8010047-2016-01495
• 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: Other
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: BML-V437QR-30
• Device Lot Number: K6620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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