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

Model Number 3890

Device Problems Break (1069); Failure to Calibrate (2440); Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  malfunction  

Event Description

The probe would not calibrate.The error reading was 'calibration sensor failure'.Vendor support was contacted.There was an unsuccessful attempt at calibrating the device."the calibration is caused by damage to the sensors on the probe" per the tech with the vendor.Last time successfully used was over a week ago.No patient harm.

• Brand Name: MANOSCAN
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): GIVEN IMAGING, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11398356
• MDR Text Key: 234235249
• Report Number: 11398356
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3890
• Device Catalogue Number: 3890
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11680 DA