MAUDE Adverse Event Report: COVIDIEN VERSASTEP PLUS AUTO SUTURE; DILATOR AND CANNULA

Model Number	VS101512P
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Covidien brand, 12mm trocar for davinci camera had a half of a pea sized plastic broke off at the distal end of the trocar.Broken piece was found barely attached to the outside of the trocar after use.Dates of use: (b)(6) 2018.Diagnosis or reason for use: uterine fibroids.

• Brand Name: VERSASTEP PLUS AUTO SUTURE
• Common Device Name: DILATOR AND CANNULA
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8164943
• Report Number: MW5082150
• Device Sequence Number: 16672249
• Product Code: GCJ
• UDI-Device Identifier: 10884521082854
• UDI-Public: (01)10884521082854
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: VS101512P
• Device Catalogue Number: (17)230731
• Device Lot Number: J8G0643X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 46