MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPEDICS VIDEOPROCESSOR; SYSTEM, IMAGE PROCESSING

Model Number SK18-SYSA0936025

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Self-Activation or Keying (1557); Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2016

Event Type  malfunction  

Event Description

During arthroscopy and orif orthopedic procedure, the computer on the tower (where you can enter the patient's information and where it has the control recordings) turned off spontaneously.It had to be reset and turned back on.When it was reset, the patient's data was missing from the system.No injury to the patient.

• Brand Name: VIDEOPROCESSOR
• Type of Device: SYSTEM, IMAGE PROCESSING
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPEDICS; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6089846
• MDR Text Key: 59596691
• Report Number: 6089846
• Device Sequence Number: 1
• Product Code: LLZ
• 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: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: SK18-SYSA0936025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1