MAUDE Adverse Event Report: NDS SURGICAL IMAGING, LLC. NDS MONITOR; CAMERA, SURGICAL AND ACCESSORIES

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Information (3190)

Event Date 12/12/2017

Event Type  malfunction  

Event Description

While positioning overhead hd monitor in the operating room for a laparoscopic case, the glass became detached from the frame of the monitor, and fell to the floor and shattered.The area was contained and cleaned.The monitor was not over the sterile field and glass was not noted on the sterile field.

• Brand Name: NDS MONITOR
• Type of Device: CAMERA, SURGICAL AND ACCESSORIES
• Manufacturer (Section D): NDS SURGICAL IMAGING, LLC.; 5750 hellyer avenue; san jose CA 95138
• MDR Report Key: 7178070
• MDR Text Key: 96843512
• Report Number: 7178070
• Device Sequence Number: 1
• Product Code: KQM
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NONE KNOWN
• Patient Age: 26 YR
• Patient Weight: 79