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

Model Number	SURGII-8
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that during a procedure, when the monopolar device activation had ended, the device continued to activate at 3/50 for a few seconds.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device was received as a service request and the reported condition was confirmed.A visual inspection and functional test were performed by the field service team.A dhr review was completed and there were no manufacturing issues related to the complaint for this serial number.Inspection of the device resulted in noting that there was moisture residue on the circuit board in several places.The device failed the visual and performance test.A root cause is currently unknown as the device needs to be sent to the supplier for analysis and repair.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.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 3299
• MDR Report Key: 6853533
• Report Number: 1717344-2017-05876
• Device Sequence Number: 1430344
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

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: 08/24/2017
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1