MAUDE Adverse Event Report: GIVEN IMAGING INC. MANOSCAN 3D; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 07/07/2015

Event Type  malfunction  

Event Description

The patient was in the procedure room for rectal manometry.The equipment was calibrated and was working correctly prior to start of the procedure.The physician was called into the procedure room to assess the probe placement.The probe recalibration was attempted multiple times and an error message was received.The patient procedure was re-scheduled.Manufacturer response: technical support was called and remotely accessed the equipment.A "tune up" was done and the equipment is now working.

• Brand Name: MANOSCAN 3D
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): GIVEN IMAGING INC.; 3950 shackleford rd., suite 500; duluth GA 30096
• MDR Report Key: 5017482
• MDR Text Key: 23528244
• Report Number: 5017482
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2015
• Event Location: Other
• Date Report to Manufacturer: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 64