MAUDE Adverse Event Report: CROSPON LIMITED ENDOFLIP MEASUREMENT CATHETER FOR USE WITH ENDOFLIP SYSTEM; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number EF-322N

Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

During endoflip set up, the catheter and syringe were inserted into the machine and the purge was started.Error message stated that test failed.

• Brand Name: ENDOFLIP MEASUREMENT CATHETER FOR USE WITH ENDOFLIP SYSTEM
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): CROSPON LIMITED; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 12727342
• MDR Text Key: 279332642
• Report Number: 12727342
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EF-322N
• Device Catalogue Number: EF-322N
• Device Lot Number: 20L0672JZ
• 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: 10/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Weight: 104