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

Model Number	784515
Medical Device Problem Codes	Break (1069); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was received and evaluated.Visual inspection of the loop found charred stains and debris as signs of use, the loop is still intact not missing.The electrode proximal end was broken at the black joint, but pin was not detached, and its internal wiring appeared to be burnt.Observed that biomaterial was found around the damaged area.Further inspection verified that the gyrus acmi plasmakinetic superpulse generator display matched the plasmakinetic supersect and superloop hf cable default settings.There are no abnormalities on both of the t shaped connectors.However, due to the broken proximal end, the electrode is no longer functional; therefore, the reported "error message output shortage" was not replicated.Based on the evaluation findings, the biomaterial debris found on the broken proximal end could have caused a short to the loop and contributed to the reported complaint.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, upon initial clinical use, the device 784515 supersect loop exhibited an error message output shortage on the generator 7440000.The intended procedure was completed with another modality.The following day, another 784515 supersect loop was used on the same generator 744000 and did not have an error.There was no patient injury or harm associated on this reported event.No user injury reported.Device evaluation found internal wiring appeared to be burnt.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the biomaterial on the broken proximal end likely caused a short to the loop and contributed to the reported error code the user received.Olympus will continue to monitor field performance for this device.

• Brand Name: PK FRONT LOADING SUPERSECT (BOX OF 5)
• Common Device Name: PK FRONT LOADING SUPERSECT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road,; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 12694635
• Report Number: 3003790304-2021-00159
• Device Sequence Number: 19173300
• Product Code: GEI
• UDI-Device Identifier: 00821925039513
• UDI-Public: 00821925039513
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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 Lot Number: U1907185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR 7440000.CABLES; GENERATOR 7440000.CABLES
• Patient Sex: Unknown