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

Model Number	9165
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was brought to operating room for a right total knee replacement with dr.The grounding pad was applied to the patient's abdomen properly and plugged into the cautery machine, which would not recognize that grounding pad was plugged in.After checking the placement of the pad and re-plugging the cord in, a new grounding pad was placed in the same spot and worked properly.Surgery was delayed as cautery couldn't be used until issue was fixed.Malfunctioning grounding pad and wrapper were brought to front desk for rn.

• Brand Name: 3M¿
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): 3M COMPANY; 3m cente, 2510 conway ave.; bldg. 275-5w-06; st paul MN 55144
• MDR Report Key: 7276918
• Report Number: 7276918
• Device Sequence Number: 2301403
• Product Code: GEI
• UDI-Device Identifier: 00707387462598
• UDI-Public: (01)00707387462598
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2018
• Report Date (Section F): 01/15/2018

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: No Information
• Device Expiration Date: 04/01/2020
• Device Model Number: 9165
• Device Catalogue Number: 9165
• Device Lot Number: 2020-04EE
• Other Device ID Number: 34-8706-8758-8
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 98
• Date Report Sent to FDA: 01/15/2018