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

Model Number	SURGII-8
Medical Device Problem Codes	Defective Alarm (1014); Energy Output Problem (1431)
Health Effect - Clinical Code	No Patient Involvement (2645)
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, the device¿s current was too high causing main voltage to fuse and went out.There was no patient involvement.The service center found the rem failed as the signal remained green between 130 and 140 ohms.
Additional Manufacturer Narrative
Evaluation summary one device was received as a service request and a visual inspection and functional test were performed.This product was being used for treatment.Inspection of the device resulted in verifying the issue with the rem failure, but not the high current or fusing.The root causes for the issues with the unit are wear and tear from long time usage and the need for preventive maintenance / calibration.As part of continuous improvement efforts and a corrective action, the supplier ran the unit through four burn-ins with no further issues found.It was subjected to full factory testing which included calibration and passed all tests with no problems or issues found.A trend analysis was performed for high current and or rem issues involving product for the past year (november 28, 2016 ¿ april 2, 2018).Two additional complaints have been received with similar defects during this time.If additional information is received, the investigation will resume as needed.This complaint will be used for trending purposes.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: 7176806
• Report Number: 1717344-2018-00040
• Device Sequence Number: 1951688
• Product Code: GEI
• UDI-Device Identifier: 10884521035928
• UDI-Public: 10884521035928
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K001955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

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: 11/30/2017
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1