MAUDE Adverse Event Report: OLYMPUS OLYMPUS LITHOCRUSH LITHOTRIPTOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/13/2014

Event Type  Injury  

Event Description

During the procedure, after partial removal of stones there was a mechanical dysfunction of the olympus litho crush lithotriptor.Multiple attempts were made to remove instrumentation and complete bile stone removal.Unfortunately this was not successful.Required common bile duct exploration.

• Brand Name: OLYMPUS LITHOCRUSH LITHOTRIPTOR
• Type of Device: LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS
• MDR Report Key: 4277169
• MDR Text Key: 18791997
• Report Number: MW5039236
• Device Sequence Number: 2
• 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: 11/19/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR