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

Model Number 173016

Patient Problem Foreign Body In Patient (2687)

Event Date 10/25/2023

Event Type  malfunction  

Event Description

The needle from an endo stich suturing device broke while suturing around a metal orvil.Unretrieved device fragment in right chest, piece of 9mm needle.Manufacturer response for covidien endo stitch 10mm suturing device, (brand not provided) (per site reporter).The covidien surgical representative was contacted and she is fling paperwork with the company regarding the event.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 18371100
• MDR Text Key: 331078412
• Report Number: 18371100
• 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: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: 170053
• Device Lot Number: J3F0527Y
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Hispanic
• Patient Race: White