MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION ALEXIS; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number GTK17

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2018

Event Type  malfunction  

Event Description

During robotic hysterectomy with bilateral salpingo oophorectomy, the trocar device with balloon was inserted in the patient's abdomen.The balloon would not inflate.No patient harm.Device to be returned to manufacturer for further review.

• Brand Name: ALEXIS
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7977042
• MDR Text Key: 124102321
• Report Number: 7977042
• 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: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GTK17
• Device Lot Number: 1314605
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2018
• Date Report to Manufacturer: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18980 DA