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

Model Number 173016

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/13/2022

Event Type  Injury  

Event Description

Patient scheduled for laparoscopic hysterectomy, using covidien endo stitch, ref# (b)(4), lot# j1m109ey, and v-loc 180, ref# (b)(4), lot# n2k0132y.While surgeon was suturing vaginal cuff and pulling needle out of tissue, the needle snapped, leaving a portion of needle in vaginal wall.Attempt was made to retrieve using both c-arm guided laparoscopic technique and open for 3.5 hours.Attempt unsuccessful leaving patient with retained foreign object.

• Brand Name: ENDO STITCH SUTURING DEVICE
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 16042559
• MDR Text Key: 306206678
• Report Number: MW5113937
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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: J1M1090EY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: C-ARM GUIDED LAPAROSCOPE
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White