MAUDE Adverse Event Report: GYRUS ACMI, INC PK BUTTON (BOX OF 5); ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	786500
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the issue is unknown at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported the unit did not work when opened.No energy flowing through the unit.According to the reporter, the user re-seated the unit however, the unit did not worked.User tried another unit and it worked.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on device return evaluation.The subject device was received and evaluated.The customer returned a pk button electrode model number 786500 lot number u2109087 for the evaluation of "unit did not work when opened.No energy flowing thru the unit." the model and lot number are based on rma paperwork as there is no visible model and lot number on the electrode.A visual inspection on the as is received condition of the device; noted that the electrode was returned along with a orange "supersect/pk button cable.The electrode and cable was not returned in its original packaging.Inspection identified what appears to be a portion of the shaft that is slightly dented and deformed.The distal end as well as the proximal end have no signs of physical damage or anomalies.A functional test was performed by using a test pk frontloading working element model number eiwe-pkfl.The orange t-shaped superpect/pk button electrode cable was inserted into the slot on the base of the white instrument actuator block with no issues.The electrode was inserted into the working element from the front, advancing the proximal end past the locking mechanism and was engaged with a click.Testing verified that the electrode proximal end was securely fastened.The connector of the electrode cable was plugged into a test 744000 gyrus generator and verified that the generator was able to recognize the customer's electrode.The default settings displayed on the generator, sp2 (200) and des(100).The distal end of the electrode was placed on top of a cotton pad soaked in saline.During testing, a test footswitch was connected and pressed on the yellow cut pedal and observed output power being provided through the distal end of the electrode and then pressed the blue coag pedal and again observed power being provided through the distal end of the electrode.The yellow and blue foot pedals were pressed several times observing output power being provided through the distal end of the electrode.Based on the device evaluation it is unable to determine the cause of customer's issue as during testing, output power was observed being provided with this device.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, output power was observed.Therefore, the cause of the customer¿s issue could not be determined.This supplemental report includes information added to e2, g2 and h4.Olympus will continue to monitor field performance for this device.

• Brand Name: PK BUTTON (BOX OF 5)
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15108563
• Report Number: 3003790304-2022-00130
• Device Sequence Number: 5255830
• Product Code: FAS
• UDI-Device Identifier: 00821925039520
• UDI-Public: 00821925039520
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K093181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2022

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: 786500
• Device Lot Number: U2109087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/29/2022
• Supplement Date Received by Manufacturer: 08/01/2022; 09/13/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/26/2022; 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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
• Patient Sex: Unknown