MAUDE Adverse Event Report: SUTURE EASE, INC. SUTURE EASE FASCIAL CLOSURE SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number SE-CB

Patient Problem Insufficient Information (4580)

Event Date 02/21/2024

Event Type  malfunction  

Event Description

Crossbow closure device misfired and tip telescoped into the instrument while attempting to remove from patient.Pa (physician's assistant) operating device believes it was caused by user error.

• Brand Name: SUTURE EASE FASCIAL CLOSURE SYSTEM
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): SUTURE EASE, INC.
• MDR Report Key: 18799633
• MDR Text Key: 336564000
• Report Number: MW5152101
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SE-CB
• Device Lot Number: CB231101
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White