MAUDE Adverse Event Report: COVIDIEN ENDOSTITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Lot Number VLOCA008L

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/26/2023

Event Type  malfunction  

Event Description

A total laparoscopic hysterectomy was being performed on a patient and during the closure of the vaginal/cervix opening a v loc suture as used.The v loc suture broke during suturing and the needle was retained in the abdomen.An attempt was made to locate the needle but was not located.Reference report: mw5118271.

• Brand Name: ENDOSTITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 17097345
• MDR Text Key: 316887844
• Report Number: MW5118270
• 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: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: VLOCA008L
• 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 Sex: Female
• Patient Weight: 33 KG
• Patient Ethnicity: Non Hispanic