MAUDE Adverse Event Report: COVIDIEN COVIDIEN TROCAR

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

It was reported that the physician was performing a laparoscopic inguinal hernia repair with mesh.As the mesh was inserted through the 12mm covidien blunt tip trocar the inner plastic ring of the trocar is pushed loose from the trocar and into the patient.Physician retrieved the plastic ring from patient, intact.Covidien rep notified of trocar incident.Dr.(b)(6) aware trend tracker to be done and covidien rep to be notified of malfunction.

• Brand Name: COVIDIEN TROCAR
• Type of Device: TROCAR
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 6940267
• MDR Text Key: 89372736
• Report Number: MW5072681
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/09/2017

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2017
• 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