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

Model Number	SURGII-8
Medical Device Problem Code	Self-Activation or Keying (1557)
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, during servicing, the unit had an error f3 which refers to having activated the monopolar handle when the equipment was configured for bipolar activations.There was no further information available at this time.There was no patient involved.
Additional Manufacturer Narrative
Additional: evaluation summary: one device was received for routine/preventative maintenance and a visual inspection and functional test were performed by the field service team.A device history record (dhr) review was completed.There were no manufacturing issues related to the complaint for this serial number.According to field service, ¿initial inspection of the equipment, seeing that the main functions are correct.The f3 error refers to having activated the monopolar handle when the equipment was set up for bipolar activations.¿ the device failed the performance test.This complaint will be considered as confirmed.A root cause analysis determined that the issue was due to ¿an error in the use of the device.¿ as part of continuous improvement efforts and a corrective action, ¿implementation of the functional verification protocol and the electrical safety test.All the values delivered by the equipment are within the parameters indicated by the manufacturer.¿ 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 drive; boulder CO 80301 3299
• MDR Report Key: 7919286
• Report Number: 1717344-2018-01284
• Device Sequence Number: 1859638
• Product Code: GEI
• UDI-Device Identifier: 10884521035928
• UDI-Public: 10884521035928
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 11/08/2018

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?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1