MAUDE Adverse Event Report: COVIDIEN VERSASTEP; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number VS101005

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

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

Event Date 09/28/2018

Event Type  malfunction  

Event Description

All 3 trocars were sticking.Whenever a 5mm device was inserted in the trocar it would be difficult to insert or remove the device.

• Brand Name: VERSASTEP
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 9877760
• MDR Text Key: 184856601
• Report Number: 9877760
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VS101005
• Device Catalogue Number: VS101005
• Device Lot Number: J8E2124X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1