MAUDE Adverse Event Report: COVIDIEN LP SURGISTAT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	SURGII-8
Medical Device Problem Codes	False Alarm (1013); Defective Alarm (1014)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device's return electrode monitoring was found out of calibration.The limit from the service manual was 135 ohms and actual value was >145 ohms, a scenario that could lead to patient harm.There was no allegation of patient death or serious injury reported.No further information was provided.
Additional Manufacturer Narrative
Evaluation summary: one surgistatii-8 device was returned for service and both visual inspection and functional testing were performed.A device history record review was completed for the unit, with no manufacturing issues related to the complaint identified for this serial number.The reported condition was confirmed.Inspection of the device found that the neutral electrode monitor (nem) was out of specification.This unit had never been in for repair or service previously and the device failed the performance test.The investigation analysis determined the root cause for the failure was that the unit was overdue for preventative maintenance and required calibration.The supplier recalibrated the nem and the unit was subjected to full factory testing / calibration.The calibrated device passed all tests with no problems or issues found.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 LP; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 7062826
• Report Number: 1717344-2017-06281
• Device Sequence Number: 155938
• Product Code: GEI
• UDI-Device Identifier: 10884521035928
• UDI-Public: 10884521035928
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K001955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: SURGII-8
• Device Catalogue Number: SURGII-8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1