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

Model Number E2350HGNSB

Device Problems Therapeutic or Diagnostic Output Failure (3023); Excessive Heating (4030)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: ROCKER SWITCH PENCIL, BLADE ELECTRODE, HOLSTER
• Manufacturer (Section D): COVIDIEN LP; 15 hamshire st; mansfield MA 02048
• MDR Report Key: 12463451
• MDR Text Key: 282980542
• Report Number: 3014527682-2021-00016
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524002217
• UDI-Public: 10884524002217
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E2350HGNSB
• Device Catalogue Number: E2350HGNSB
• Device Lot Number: 203350344R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1