MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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 02/07/2017

Event Type  Injury  

Manufacturer Narrative

The subject product was returned to omsc for investigation on (b)(6) 2017.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.In addition, the basket was deformed.Moreover, the distal end of the coil sheath was buckled.As checking dhr of the same lot for the subject device, nothing abnormal related to the reported event was detected on the following items (1) outer diameter of the basket wire (2) deformation of the basket wire (3) outer diameter of the operating wire (4) overflown length of the brazing filler at the brazed part (5) outer diameter of the brazing part (6) outer appearance of the brazing part from the conditions of the subject device, it is surmised that during crushing the calculus, a large load more 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 and the breakage at the junction between the operation pipe and the basket wire.As described in the instruction manual, this subject 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.Different parts of the device break depending on the situation such as the shape of a calculus, bending shape of a coil sheath, etc.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, notable coil sheath bent or gap etc.).

Event Description

During an endoscopic bile duct calculus exclusion method on (b)(6) 2017, 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 subject device got stuck in the patient.The doctor released the stuck device and removed from the patient by an endoscopic operation.After that, the doctor discontinued the procedure.In addition, the doctor considers that the cause of stuck in the patient is due to hard calculus.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: SINGLE USE MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 8142642517
• MDR Report Key: 6375387
• MDR Text Key: 68964133
• Report Number: 8010047-2017-00242
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial

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: No Information
• Device Model Number: BML-V437QR-30
• Device Lot Number: K6Y07
• Other Device ID Number: 04953170218415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• 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