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

Model Number HACF0533

Device Problem Failure to Conduct (1114)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 319581312
• Report Number: 3011050570-2023-00087
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925036390
• UDI-Public: 00821925036390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1