MAUDE Adverse Event Report: ADVANCE MEDICAL DESIGNS, INC. CAMERA HANDLE COVER; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 06-CLK03

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/18/2018

Event Type  malfunction  

Event Description

Camera handle cover fell off during surgical procedure into patient wound.

• Brand Name: CAMERA HANDLE COVER
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): ADVANCE MEDICAL DESIGNS, INC.; 1241 atlanta industrial drive; marietta GA 30066
• MDR Report Key: 7658558
• MDR Text Key: 113025605
• Report Number: 7658558
• Device Sequence Number: 1
• Product Code: JAA
• 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: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 06-CLK03
• Device Lot Number: 70232C7081
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2018
• Event Location: Operating Room
• Date Report to Manufacturer: 07/03/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA