MAUDE Adverse Event Report: OLYMPUS LITHOTRIPTOR V; LITHOCRUSH

Model Number BML-V442QR-30

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2015

Event Type  malfunction  

Event Description

During ercp lithocrush v device was inserted to break up gall stone.After attaching to gall stone and crushing it, the device disengaged from insertion portion and traveled to bile duct.Device was able to be retrieved after an add'l 20 minutes.Outcome: add'l time under general anesthesia, no harm or complications noted at this time.

• Brand Name: LITHOTRIPTOR V
• Type of Device: LITHOCRUSH
• Manufacturer (Section D): OLYMPUS; anchorage AK 99508
• MDR Report Key: 4905572
• MDR Text Key: 6536567
• Report Number: MW5043891
• Device Sequence Number: 1
• Product Code: FEO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: BML-V442QR-30
• Device Catalogue Number: BML-V442QR-30
• Device Lot Number: 4XK
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 104