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

Model Number CTF73

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2020

Event Type  malfunction  

Event Description

During a laparoscopic gastric bypass procedure, a trocar port was leaking.The procedure was still completed as planned without excessive delay or harm to the patient.

• Brand Name: KII FIOS FIRST ENTRY TROCAR
• 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: 10476097
• MDR Text Key: 205110265
• Report Number: 10476097
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2020

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: No Information
• Device Model Number: CTF73
• Device Lot Number: 1382749
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11315 DA
• Patient Weight: 184