MAUDE Adverse Event Report: COVIDIEN COVIDIEN VERSAONE / OPTICAL TROCAR WITH FIX CANNULA; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number ONB5STF

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

Could not get obturator out of sleeve.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN VERSAONE / OPTICAL TROCAR WITH FIX CANNULA
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10319728
• MDR Text Key: 200600288
• Report Number: MW5095691
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: ONB5STF
• Device Lot Number: J8K0464JRX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 82