MAUDE Adverse Event Report: GENICON CANNULA; TROCAR CANNULA

Model Number 100-010-151

Device Problem Fracture (1260)

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

Event Date 09/17/2018

Event Type  malfunction  

Event Description

A genicon 10x100mm cannula fractured during a laparoscopic adrenalectomy.A 1mmx2mm was possibly left behind in the patient.

• Brand Name: CANNULA
• Type of Device: TROCAR CANNULA
• Manufacturer (Section D): GENICON; 6869 stapoint court; suite 114; winter park FL 32792
• Manufacturer (Section G): GENICON; 6869 stapoint court; suite 114; winter park FL 32792
• Manufacturer Contact: katlyn kachman ; 6869 stapoint court; suite 114; winter park, FL 32792 ; 4076574851
• MDR Report Key: 7951711
• MDR Text Key: 123376630
• Report Number: 3002590791-2018-00004
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K982472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100-010-151
• Device Catalogue Number: 100-010-151
• Device Lot Number: I9484-G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention