MAUDE Adverse Event Report: OLYMPUS OLYMPUS CHOLEDOCHOSCOPE

Model Number 2802515

Device Problems Leak/Splash (1354); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

Event Type  malfunction  

Event Description

During ercp, our scope tech and physician were unable to pass wire through scope had to change scopes, and the loaner scope had to have hld prior to use on pt causing 47 min delay.No harm to the pt.Once procedure was completed, found leak in loaner scope.

• Brand Name: OLYMPUS CHOLEDOCHOSCOPE
• Type of Device: CHOLEDOCHOSCOPE
• Manufacturer (Section D): OLYMPUS
• MDR Report Key: 6380480
• MDR Text Key: 69255966
• Report Number: MW5068266
• Device Sequence Number: 1
• Product Code: FBN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2802515
• Is the Reporter a Health Professional?: Yes
• 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: 55 YR
• Patient Weight: 62