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

Model Number BML-V232QR-30

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

Olympus medical system corp (omsc) was informed that during crushing hard stone which size was about 2cm in the bile duct, the wire broke.The doctor attempted to crush it with emergency handle but it broke again.Then, the doctor tried to remove the broken wire from papilla by using a snare but he couldn't since the stone lodged in the pt body.He continued to push and pull the device and the stone came free from the wire.Finally, he could remove the subject product from the pt.Reportedly, the pt will receive open surgery to remove the stone.

Manufacturer Narrative

The subject product was returned to omsc for investigation.The investigation confirmed that the basket wire was broken at the junction with the pipe.There were no abnormalities found upon investigation of the condition of the solder part and the outer diameter of the pipe.The basket was deformed and the coil sheath had slips.In addition, the basket wire also broke at about 1310 mm from the distal end of the basket and the broken portion was extended.As the checking of the manufacturing record of the same lot, nothing abnormal detected.Omsc considers that the condition of patient or calculus caused the failure of crushing calculus and the breakage.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.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4407130
• MDR Text Key: 15817174
• Report Number: 8010047-2015-00027
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2014

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: Other
• Device Model Number: BML-V232QR-30
• Device Lot Number: K4711
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1