MAUDE Adverse Event Report: 3M COMPANY 3M¿; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	9165
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
3m universal electrosurgical pad: split with cord used with another device malfunctioned.This product is not supplied by the manufacturer of the machine.

• Brand Name: 3M¿
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): 3M COMPANY; 600 east meigs st.; valley NE 68064
• MDR Report Key: 7771827
• Report Number: 7771827
• Device Sequence Number: 1118805
• Product Code: GEI
• UDI-Device Identifier: 00707387462598
• UDI-Public: (01)00707387462598
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2018
• Report Date (Section F): 08/03/2018

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: 9165
• Device Catalogue Number: 9165
• Device Lot Number: 202103DT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/03/2018