MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORP. KII FIOS FIRST ENTRY; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number CTF03

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2019

Event Type  malfunction  

Event Description

Trocar was being introduced into a patient's laparoscopic incision for a cholecystectomy.The trocar shaft bent during insertion.There device was removed intact and there was no harm to the patient.

• Brand Name: KII FIOS FIRST ENTRY
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORP.; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8343355
• MDR Text Key: 136262934
• Report Number: 8343355
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CTF03
• Device Catalogue Number: CTF03
• Device Lot Number: 1347122
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Weight: 77