MAUDE Adverse Event Report: GYRUS ACMI, INC. HALO PKS CUTTING FORCEPS,5MM/33CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	HACF0533
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the halo pks cutting forceps,5mm/33cm had no power.The event occurred during a therapeutic laparoscopic tubal ligation procedure.The procedure was completed with a similar device.There was no patient harm associated with the event.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was not returned.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 root cause was unable to be determined.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned and inspected.Based on the results of the investigation, the event of ¿no output¿ was not confirmed.The device was able to coagulate a tissue sample without an issue and working as designed.Other device findings were as follows: the observed cracks/scratches on the insulation of the jaw legs can be attributed to user mishandling during use.However, potential causes of the reported failure could not be conclusively specified.The suggested events can be prevented by handling the device in accordance with the following instructions for use (ifu): ¿for optimum performance, keep jaw surfaces free of debris; both coagulating surfaces should be in equal contact with tissue for optimum coagulation." the cause of the reported event cannot be conclusively determined.Olympus will continue to monitor field performance for this device.

• Brand Name: HALO PKS CUTTING FORCEPS,5MM/33CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18057115
• Report Number: 3011050570-2023-00170
• Device Sequence Number: 6877698
• Product Code: GEI
• UDI-Device Identifier: 00821925036390
• UDI-Public: 00821925036390
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100896
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2024

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: HACF0533
• Device Lot Number: FR322734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 01/08/2024; Not provided
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 01/10/2024; 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown