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

Model Number 173016

Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/27/2023

Event Type  malfunction  

Event Description

Endo stitch used intraoperatively.The needle came loose and stayed in patient's vaginal cuff.After using the device, it was noted that the full needle was not returned.This area was searched and in real time it appeared that the full needle was retrieved.Upon a closer look, it was determined that a small portion of the t-shaped needle was still in the patient.It was determined that the size of the portion of the needle that remained inside of the patient was 3-4 mm and would not show up on x-ray.Also, the location of the portion of the needle was at a location that would have caused more harm to retrieve.It was reported that the device did not function as expected.After firing the stitch, when the device was pulled out the needle was no longer attached.The surgical team worked to retrieve the needle.They pulled out what was believed to be the needle.With further inspection, the team realized the complete needle was not retrieved.When that was realized it was determined that it would be more harmful to the patient to keep exploring the rest of the needle.The size that was left was 3-4 mm and that would not show up on x-ray.The device is in materials management.The device is a disposable and would not be going to biomed.Staff is notifying the manufacturer.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 16960693
• MDR Text Key: 315548502
• Report Number: 16960693
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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: J2H1003EY
• 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: 05/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21900 DA
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Race: White