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

Model Number	HACF0533
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.A supplemental report will be submitted if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the halo pks cutting forceps, are not conducting any cautery, and the instrument is not firing at all.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Sections d4, e2, and e3 were corrected with information that was inadvertently omitted from the initial report.Sections d9, h4, h6, and h10 were updated.Additional information about the event was requested, but not available.If new information is received, an additional supplemental report will be submitted.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 device was returned inside a cardboard box with air cushion packaging material.None of the original packaging was received.The jaws were received in the "open" position and the lock was in the "on" position.Th definitive root cause of the firing issue could not be determined.When the jaws were closed, there was a bad mesh, which is likely due to the bent jaws.The blade was still able to be extended when the jaws were closed with no issues.The jaws were able to be opened and closed with no issues.The locking mechanism worked as intended in both the "on" and "off" positions.The blade was sharp and had no issues extending and retracting.It is possible that the bent jaws caused a bad mesh, which may have resulted in excessive grasping errors when attempting to coagulate.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: 17374709
• Report Number: 3011050570-2023-00087
• Device Sequence Number: 17894761
• Product Code: GEI
• UDI-Device Identifier: 00821925036390
• UDI-Public: 00821925036390
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: FR303798
• 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: 06/23/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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