MAUDE Adverse Event Report: COVIDIEN LP ENDOFLIP 8CM NASAL TIP 16; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number EF-325N

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/27/2022

Event Type  malfunction  

Event Description

No injury to patient, when catheter connected to syringe, computer system reported "error" on the screen.

• Brand Name: ENDOFLIP 8CM NASAL TIP 16
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 14976120
• MDR Text Key: 295609269
• Report Number: 14976120
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EF-325N
• Device Lot Number: 22CI754JZ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1