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

Model Number CTF33

Device Problem Bent (1059)

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

Event Date 05/16/2017

Event Type  malfunction  

Event Description

The 11mm applied medical trocar ref#ctf33 shaft bent on inserting into patient.

• Brand Name: KII FIOS FIRST ENTRY
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6852099
• MDR Text Key: 85374849
• Report Number: 6852099
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2017,07/31/2017

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: Physician
• Device Expiration Date: 12/05/2019
• Device Model Number: CTF33
• Device Lot Number: 1284581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2017
• Type of Device Usage: N
• Patient Sequence Number: 1