MAUDE Adverse Event Report: SUNQUEST INFORMATION SYSTEM SUNQUEST COPATHPLUS

Device Problem Loss of Data (2903)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2014

Event Type  malfunction  

Event Description

While using the copathplus quick sign-out reports feature, if a user presses the keyboard shortcut "crl-z" while editing text in a diagnostic text field, portions of previously saved text may disppear upon saving the report.While using the copathplus quick sign-out reports feature, if a user presses the keypad shortcut "ctrl o" the application may close unexpectedly.

Manufacturer Narrative

Fourteen sites have been notified via product safety notice (psn) and a correction will be available in copathplus version 6.1.1 and above.There are 0 sites that have already been corrected.Steps to reproduce: logon as sunquest user and accession a surgical specimen.Navigate to the electronic signout for final report window for the specimen.Enter a large amount of text in the final diagnosis field and then click on save/quick sign/out to open the quick sign out report.Add some text to the first paragraph of the final diagnosis textfield and click ctrl-z to undo these additions.Click on edit specimen and then on ok to save changes.On returning to the electronic signout for final report notice that the first paragraph of the diagnosis is missing.Click on save/quick sign/out to open the quick sign out report.Click ctr-o and a system error window is displayed.If the user click ok then the copath application closes down.

• Brand Name: SUNQUEST COPATHPLUS
• Type of Device: COPATHPLUS
• Manufacturer (Section D): SUNQUEST INFORMATION SYSTEM; 250 s. williams blvd; tucson AZ 85711
• Manufacturer Contact: patrice nedelec, vp client exper ; 250 s. williams blvd; tucson, AZ 85711 ; 5205702317
• MDR Report Key: 3938587
• MDR Text Key: 4577630
• Report Number: 2029302-2014-00001
• Device Sequence Number: 1
• Product Code: NVV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Other Device ID Number: VERSION 6.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1