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 12/08/2015

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.As the checking of the manufacturing record of same lot, nothing abnormal was detected.Therefore, omsc assumes that the condition of the patient or stone might cause this event.The device instruction manual has warned users that there is possibility the calculus cannot be crushed by lithotriptor, and it also describes what to do if the lithotriptor cannot crush the calculus.

Event Description

The doctor attempted to crush a bile duct calculus using the subject device.Since a calculus was hard, it failed to work.Then the calculus became incarcerated, and the pipe of this device broke off.The doctor completed the treatment by removing the device after the incision the papilla of a patient.The patient was hospitalized as scheduled.The doctor plans to re-try crushing the calculus to the patient for another day.

• 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: 5318687
• MDR Text Key: 34130674
• Report Number: 8010047-2015-01349
• 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: 12/24/2015

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: K5X08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2015
• 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