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

Model Number BML-V232QR-26

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/29/2014

Event Type  malfunction  

Event Description

Olympus medical systems corp, (omsc) was informed that during crushing calculus with the lithotriptor, the device broke.The pt suffered acute cholecystitis and had erbd (endoscopic retrograde biliary drainage).After doctor removed drainage tube and attempted to crush calculus using different three lithotriptors.First, he used boston's lithotriptor, but he intuitively thought that it could not crush calculus when he caught calculus into the basket.Then, he used zeon medical's lithotriptor, but he also thought it could not crush due to its soft sheath, so he chose the subject device.However, it snapped near handle while he was crushing calculus.He cut the sheath and withdrew it from the pt.After the procedure he discussed about surgery with the pt and decided to insert drainage tube and monitor again.The pt was in the hospital now and it was undecided discharge.

Manufacturer Narrative

The subject device was returned to omsc for investigation.The investigation confirmed that the pipe was broken at the junction with the wire.There were no abnormalities found upon investigation of the condition of the connection part.As the result of checking the mfg record of the same lot, there were also no abnormalities noted that may lead to the breakage.The calculus turned out to be hard according to the report by facility.Therefore, omsc considers that the calculus was too hard to crush and it caused the breakage of the lithotriptor.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 CORP.; 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: 3745588
• MDR Text Key: 4222483
• Report Number: 8010047-2014-00097
• 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: 02/24/2014

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: Health Professional
• Device Model Number: BML-V232QR-26
• Device Catalogue Number: BML-V232QR-26
• Device Lot Number: K3110
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/07/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1