MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN COVIDIEN ENDO STITCH SUTURING DEVICE 10 MM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

Device Problem Activation Problem (4042)

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

Event Date 01/11/2023

Event Type  malfunction  

Event Description

Covidien endo stitch suturing device 10 mm, ref: 173016, lot "j2f1921ey", exp: 05/31/2027 would not function properly.In attaching to the polysorb suture, another endostitch had to be opened for surgery.The suture was not used on the pt.The surgical tech was trying to load the suture on the device, and it was not loading correctly.This did not cause any harm to the pt, and the suture and device was removed from the field.This did not cause any delays in the operating room.They were able to get another device that worked properly.

• Brand Name: COVIDIEN ENDO STITCH SUTURING DEVICE 10 MM
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): MEDTRONIC / COVIDIEN; minneapolis MN 55432
• MDR Report Key: 16235000
• MDR Text Key: 308097802
• Report Number: MW5114469
• 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: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Lot Number: J2F1921EY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Female