MAUDE Adverse Event Report: OLYMPUS LITHOTRIPTOR

Model Number BML-V232QR-30

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/12/2015

Event Type  Injury  

Event Description

While performing a ercp and attempting to remove stones from common bile duct, the olympus lithotripter basket became lodged in the bile duct.Doctor attempted to use olympus crank device to retrieve the basket from the bile duct and wires snapped away from the pins on the crank device.

• Brand Name: LITHOTRIPTOR
• Type of Device: LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS; 3500 corp parkway; valley PA 18034
• MDR Report Key: 4645529
• MDR Text Key: 18033486
• Report Number: MW5041737
• Device Sequence Number: 1
• Product Code: LQC
• 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: 03/24/2015

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: Health Professional
• Device Model Number: BML-V232QR-30
• Device Catalogue Number: BML-V232QR-30
• Device Lot Number: BML-V232QR-30
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR