MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION ALEXIS LAPAROSCOPIC SYSTEM WITH KII FIOS FIRST ENTRY; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number C8701

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2019

Event Type  malfunction  

Event Description

Alexus laparoscopic cap, (no patient harm).Failed alexus product.

• Brand Name: ALEXIS LAPAROSCOPIC SYSTEM WITH KII FIOS FIRST ENTRY
• 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: 9140055
• MDR Text Key: 160778122
• Report Number: 9140055
• 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: 08/07/2019

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: Health Professional
• Device Model Number: C8701
• Device Catalogue Number: C8701
• Device Lot Number: 1350774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1