MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	E2100
Medical Device Problem Codes	Self-Activation or Keying (1557); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the pencil had no visual defects and was tested for self activation, and failed.The coagulation button was activating without pressing of the button.The cut function of pencil tested satisfactorily and the electrode insertion/extraction was within the specification.The pencil passed hipot testing.Also, the device was disassembled and the mechanical rocker showed no physical damage.The dome switches were adequate, there was good tactile feedback.When removing the over mold of pencil, the support switch was relieved of pressure and the self-activation ceased.It has been determined that during assembly, too much pressure was put on the support switch resulting in not enough space between the contacts that activate the pencil when they touch.It was reported that the device did not activate when keyed.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the unit had a self-activation on switch failure.The most likely cause was determined to be manufacturing related.The event has foreseen risk and is included in a data monitoring plan.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, did not activate.Another device was use and worked fine.The initial investigation detected a unreported condition of self-activation.There was no patient injury.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13053873
• Report Number: 1717344-2021-01674
• Device Sequence Number: 13868626
• Product Code: GEI
• UDI-Device Identifier: 20884524001590
• UDI-Public: 20884524001590
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K942183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

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: E2100
• Device Catalogue Number: E2100
• Device Lot Number: 01170193V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown