MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN SITUATE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Catalog Number G0404-16P01C-1

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

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

Event Date 12/31/2021

Event Type  malfunction  

Event Description

A 61f adm for robotic laparoscopy, total lap hysterectomy, sentinel lymph node mapping w/biopsy; robotic and lap salpingo-oophorectomy.Rf sponge inserted through 8mm trocar for the purpose of hemostasis resulted in rf bead becoming dislodged and retained in the patient.Rf wanding post procedure did not locate bead.Abdominal xray found damaged rf bead and was removed from patient without harm.Fda safety report id# (b)(4).

• Brand Name: SITUATE
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): MEDTRONIC / COVIDIEN
• MDR Report Key: 13358701
• MDR Text Key: 284620256
• Report Number: MW5106982
• Device Sequence Number: 1
• Product Code: GDY
• 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: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/05/2022
• Device Catalogue Number: G0404-16P01C-1
• Device Lot Number: 210401AT
• 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
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian