MAUDE Adverse Event Report: GYRUS ACMI, INC PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK); PKS CUT/FCP ENERGY DEVICES

Model Number	920005PK
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to the service center for evaluation.The device evaluation is pending, therefore, the root cause of the reported phenomenon could not be determined at this time.Additional event/patient information has been requested this report will be supplemented accordingly following investigations.
Event or Problem Description
It was reported that during a laparoscopic salpingo-oophorectomy procedure the handpiece device would not fire when inserted through the port to cauterize a bleed.An unknown delay to the procedure was noted.The intended procedure however was completed using another handpiece.The serial number used was not provided.The event according to the reporter slowed down the procedure.There was no patient serious injury or medical intervention reported due to the event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The returned device was evaluated.Inspection indicates that there is minor dried tissue on the bottom jaw consistent with use.The device jaws had symmetry and a distal tip distance that were among the standard.The jaw mesh was normal, and the cutting feature was able to cut the dental dam as designed.When plugged into a generator, there were no error codes.Additionally, when plugged into the generator, the distal jaws were able to heat up and coagulate as designed.The functionality of the device was tested multiple times with different power outputs and the device heated up as intended.Based on the device evaluation, it is unable to replicate the user complaint of device would not fire as the device was functioning properly as intended, however inspection did observe slits in the insulation exposing metal which could possibly attribute to the customer's issue.The observed failure is a known phenomenon and is produced as a result of error in operating the device.On page 2 of the device ifu (910111-001_ee), error in lack of coagulation is addressed: "warning: insufficient generator output time or generator output level may not provide the operator with the desired level of coagulation." the dhrs (device history records for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Olympus will continue to monitor the field performance of this device.

• Brand Name: PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK)
• Common Device Name: PKS CUT/FCP ENERGY DEVICES
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11785761
• Report Number: 3011050570-2021-00072
• Device Sequence Number: 19735617
• Product Code: GEI
• UDI-Device Identifier: 00821925036178
• UDI-Public: 00821925036178
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K023492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: 920005PK
• Device Lot Number: FR103782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 05/28/2021
• 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: FOOT PEDAL.