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

Model Number BML-V232QR-26

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2015

Event Type  malfunction  

Event Description

Olympus medical system corp.(omsc) was informed that during endoscopic retrograde cholangio pancreatography (ercp), the operation pipe broke.The doctor withdrew the subject device from the patient and attempted to crush the stone with another bml-v232qr-26 but the coil sheath was deformed.He thought that the breakage of the device might occur again if he continued to perform the procedure and abandoned it.After 5 days, the doctor crushed 4 or 5 stones including about 3cm large size stone.The patient was recovering.

Manufacturer Narrative

The subject 2 devices were returned to omsc for investigation.The device which was initially used was broken at the junction with the basket wire and the pipe.There were no abnormalities found upon investigation of the condition of the welded part.The basket was deformed.The basket of the second device was also deformed.In addition, there were slips on the coil sheath.As the checking of the manufacturing record of the same lot, nothing abnormal detected.According to the investigation and report from the user facility, omsc considers that the condition of patient or calculus caused the failure of crushing calculus and the breakage.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 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4568347
• MDR Text Key: 5547326
• Report Number: 8010047-2015-00138
• 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: 02/04/2014

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-26
• Device Lot Number: K4618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BML-V232QR-26 (MDR# 8010047-2015-00154)
• Patient Age: 60 YR