MAUDE Adverse Event Report: CROSPON LIMITED ENDOFLIP; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number EF-325N

Device Problems Defective Device (2588); Protective Measures Problem (3015)

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

Event Date 07/22/2021

Event Type  malfunction  

Event Description

The catheter and syringe were plugged into the endoflip machine to make sure it was working correctly and as the machine was doing its checks it came up an error saying there was something wrong with the catheter.Removed the non functioning catheter.No injury or potential injury to the patient.

• Brand Name: ENDOFLIP
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): CROSPON LIMITED; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 12280321
• MDR Text Key: 265157148
• Report Number: 12280321
• 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: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• 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: 20E0587JZ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1