MAUDE Adverse Event Report: COVIDIEN ENDO STITCH (AUTOSUTURE); ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

While using the endostitch on bladder wall, stitch successfully passed through first layer of tissue but upon toggling through to the second layer the stitch didn't pass through the tissue and became retained in bladder.Bladder was thick tissue, md unsure if endostitch device malfunctioned or just thick tissue for passing suture caused the issue.

• Brand Name: ENDO STITCH (AUTOSUTURE)
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 17388212
• MDR Text Key: 319668875
• Report Number: 17388212
• Device Sequence Number: 1
• Product Code: OCW
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J2M0550EY
• 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: 06/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Female
• Patient Weight: 126 KG
• Patient Race: White