MAUDE Adverse Event Report: COVIDIEN LLC MANOSCAN; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Lot Number EAZ4164A

Device Problem Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

Manometry probe possible malfunction with impedance recording.Technical support for medtronic, supporting company, stated there is a short in the impedance function of the manometry probe and are sending a new probe (current probe under warranty).

• Brand Name: MANOSCAN
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): COVIDIEN LLC; 3062 bunker hill lane; santa clara CA 95054
• MDR Report Key: 15949666
• MDR Text Key: 305169138
• Report Number: 15949666
• 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: 12/05/2022,11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: EAZ4164A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Sex: Female