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

Model Number	E2516H-GNSB
Medical Device Problem Codes	Self-Activation or Keying (1557); Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the unit had a latch on switch failure.It was reported that the device was not detected by the unit.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device was non-responsive when plugged into the generator.Medtronic troubleshooting of the returned device found that when the pencil was self activating in the cut mode when plugged into the generator and 40 kohm box.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 10624508
• Report Number: 1717344-2020-01158
• Device Sequence Number: 2628063
• Product Code: GEI
• UDI-Device Identifier: 10884524003016
• UDI-Public: 10884524003016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K813071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2020

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: E2516H-GNSB
• Device Catalogue Number: E2516H-GNSB
• Device Lot Number: 200240114R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 10/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1