MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER SURGISTAT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VLSURGGEN
Medical Device Problem Codes	Inaccurate Delivery (2339); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, the unit had an error code e4 and failing return electrode monitoring (rem) test.During the rem test the unit did not alarm at the minimum 3 ohm value that is should have alarmed at.It did not alarm unit zero ohms.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one device was received as a service request and a visual inspection and functional test were performed.The returned device did not meet specification as received by the supplier.The reported condition was confirmed for the nem issue, not for the e4 error code.According to the technician, "issue confirmed for nem out of calibration.Found the split pad low limit out of specifications with a reading of 1.Issue not confirmed for e4 error.Note because it has not approved the main board upgrades random e4 may be seen." the investigation found the most probable cause of the reported event to be wear and tear for the nem issue.The nem was calibrated.The unit was subjected to full factory testing / calibration with qa-327_22.It passed all tests with no problems or issues found.The risk management file is managed by the supplier.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGISTAT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301
• MDR Report Key: 9647736
• Report Number: 1717344-2020-00095
• Device Sequence Number: 2791118
• Product Code: GEI
• UDI-Device Identifier: 10884521517417
• UDI-Public: 10884521517417
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K001955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: VLSURGGEN
• Device Catalogue Number: VLSURGGEN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1