MAUDE Adverse Event Report: COVIDIEN CLEARIFY VISUALIZATLON SYSTEM TAMPON; ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY

Catalog Number 21-345

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/26/2023

Event Type  Injury  

Event Description

The trocar was cleaned with the device (tampon) and upon removing from the umbilicus, the tip of the sponge was missing.It could not be located and procedure completed with retained polyurethane foam tip.Surgeon's plan is to monitor and potentially use ultrasound at later date to locate.Plan will depend on pt's condition.Medtronic's rep aware.Pt was hospitalized add'l day but no known harm at current time.

• Brand Name: CLEARIFY VISUALIZATLON SYSTEM TAMPON
• Type of Device: ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 16854050
• MDR Text Key: 314472695
• Report Number: MW5117192
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-345
• Device Lot Number: D2M1058Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 83 KG