MAUDE Adverse Event Report: GYRUS ACMI, INC PK FRONT LOADING SUPERSECT (BOX OF 5); ELECTRODES, PROBES

Model Number	784515
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.This report will be supplemented accordingly following investigations.
Event or Problem Description
It was reported that during an unspecified procedure the device element caused the generator to reset.An error code 100 occurred.There was a three minutes delay however, the intended procedure was completed with another device.There was no patient impact, no user harm reported.
Additional Manufacturer Narrative
This report is being supplemented to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: PK FRONT LOADING SUPERSECT (BOX OF 5)
• Common Device Name: ELECTRODES, PROBES
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road,; southborough MA 01772
• MDR Report Key: 11515984
• Report Number: 3003790304-2021-00051
• Device Sequence Number: 3827812
• Product Code: GEI
• UDI-Device Identifier: 00821925039513
• UDI-Public: 00821925039513
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K031085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 784515
• Device Catalogue Number: 784515
• Device Lot Number: U1912123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR