MAUDE Adverse Event Report: APPLIED MEDICAL; TROCAR

Catalog Number CTF 503

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2018

Event Type  malfunction  

Event Description

Surgeon used "a" applied medical 5 mm trocar and while in use the inner piece of the trocar came out in the patient's abdomen.The piece was retrieved by the surgeon.There was no harm to the patient.Per hospital, the manufacturer was notified.Materials management to return to the manufacturer upon request.

• Type of Device: TROCAR
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8114581
• MDR Text Key: 128732774
• Report Number: 8114581
• Device Sequence Number: 0
• Product Code: DRC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CTF 503
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Weight: 153