MAUDE Adverse Event Report: COVIDIEN LP EDGE; ROCKER SWITCH PENCIL, BLADE ELECTRODE, HOLSTER

Model Number	E2350HGNSB
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The cautery pencil was working improperly and the tip was to hot to use.There was patient contact but no harm to the patient.No delay to the case.Another cautery was pulled from sterile stock and used for the procedure.The cautery pencil is a component contained within a custom procedure kit built by roi cps, llc.Kit 880030015, lot 891190.
Additional Manufacturer Narrative
The cautery device contained in this report is not manufactured by roi cps, llc.The device is purchased and used as a component within custom procedure kits manufactured by roi cps, llc.

• Brand Name: EDGE
• Common Device Name: ROCKER SWITCH PENCIL, BLADE ELECTRODE, HOLSTER
• Manufacturer (Section D): COVIDIEN LP; 15 hamshire st; mansfield MA 02048
• MDR Report Key: 12463451
• Report Number: 3014527682-2021-00016
• Device Sequence Number: 3787606
• Product Code: GEI
• UDI-Device Identifier: 10884524002217
• UDI-Public: 10884524002217
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

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: E2350HGNSB
• Device Catalogue Number: E2350HGNSB
• Device Lot Number: 203350344R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1