MAUDE Adverse Event Report: OLYMPUS OLYMPUS LITHOTRIPTOR HANDLE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/26/2017

Event Type  malfunction  

Event Description

Olympus lithotriptor handle/crusher malfunctioned.Rescue handle used and wire cut by dr noyer to complete the procedure/ercp.

• Brand Name: OLYMPUS LITHOTRIPTOR HANDLE
• Type of Device: LITHOTRIPTOR HANDLE
• Manufacturer (Section D): OLYMPUS
• MDR Report Key: 6636364
• MDR Text Key: 77561379
• Report Number: MW5070367
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR