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	04/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient brought to the or for a laparoscopic sleeve gastrectomy with dr.After intubation and positioning, grounding pad was applied to the patient's lateral thigh and plugged into cautery machine.Cautery machine began alarming that cautery pad was not attached, although pad was still attached to patient.Pad was unplugged and plugged back in and continued to register and unregister the grounding pad being attached to the patient.Grounding pad was removed and placed in the packaging it came in, and a new, functioning pad was placed.No patient harm.

• Brand Name: 3M¿
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave. bldg. 275-5w-06; st. paul MN 55144
• MDR Report Key: 7533803
• Report Number: 7533803
• Device Sequence Number: 152196
• 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): 05/04/2018
• Report Date (Section F): 05/04/2018

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: Physician
• Device Expiration Date: 01/01/2021
• Device Model Number: 9165
• Device Catalogue Number: 9165
• Device Lot Number: 202101BA
• Other Device ID Number: 34-8706-8758-8
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 153
• Date Report Sent to FDA: 05/04/2018