MAUDE Adverse Event Report: COVIDIEN 12MM LONG VERSASTEP PLUS AUTOSUTURE DILATOR AND CANNULA; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number VS101512P

Device Problems Break (1069); Component Missing (2306)

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

Event Date 01/18/2019

Event Type  malfunction  

Event Description

During laparoscopic cholecystectomy, a small plastic piece of the 12 mm trocar broke while in use and could not be located.

• Brand Name: 12MM LONG VERSASTEP PLUS AUTOSUTURE DILATOR AND CANNULA
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 8286481
• MDR Text Key: 134706324
• Report Number: MW5083449
• 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: Unknown
• Type of Report: Initial
• Report Date: 01/24/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: VS101512P
• Device Catalogue Number: VS101512P
• Device Lot Number: J6L0313X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2019
• 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: 25 YR
• Patient Weight: 107