MAUDE Adverse Event Report: GYRUS ACMI, INC HALO PKS CUTTING FORCEPS,5MM/33CM

Model Number HACF0533

Device Problems No Device Output (1435); Defective Device (2588)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.This report will be supplemented accordingly following investigations.

Event Description

As reported, the device has failed, the device did not coagulate at all.Another same like device from the same box was used and the procedure was able to be completed.The issue occurred in the beginning of a hysterectomy procedure.No patient harm or injury reported due to the event.No user injury was reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on device evaluation and legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h3,h4, h6 and h10.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.No associated ncrs (non conformances), reported scrap or recorded process deviations relating to the reported failure.Visual inspection upon the received condition found jaw open and lock on.The handle was checked and verified that the release trigger could open or close the jaw without an issue.The cut trigger could fully advance the blade and cut the dental dam without a restriction.The lock and rotation knob work as designed.The shaft is straight, and the cord connector is in good condition.There are no dried tissues on jaw.The jaw symmetry is balanced, and the jaw mesh is good.The flare and insulation of jaw legs have no physical damage.The jaw aperture measurement was taken inside the first teeth of the jaw, measured at.332¿¿ (standard is.300¿ +/-.100¿) which is acceptable.The jaws could grasp a tissue and lock into position without an issue.The device was then plugged into the test generator g400, the generator automatically displayed a default setting vp3/35.Verified led on handpiece lit up.Confirmed the device did have energy output at the jaws when the blue coag switch button was activated.It was able to complete coagulation as a tone drop signified an increase in impedance, and cut a saline soaked gauze pad during testing.Based on the evaluation findings, the reported complaint was not confirmed.The device was able to coagulate a tissue sample without an issue and working as designed.The observed failure is a known phenomenon likely resulting from error in connecting the device correctly and/or a failure in accurately activating the device for coagulation.On page 3 of the device ifu (instruction for use), it states: activate the electrosurgical function by depressing the coagulation button at the rear of the handpiece or the generator footswitch.Olympus will continue to monitor the field performance of this device.

• Brand Name: HALO PKS CUTTING FORCEPS,5MM/33CM
• Type of Device: HALO PKS CUTTING FORCEPS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12417725
• MDR Text Key: 283145638
• Report Number: 3011050570-2021-00102
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925036390
• UDI-Public: 00821925036390
• Combination Product (y/n): N
• PMA/PMN Number: K100896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

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
• Device Operator: Health Professional
• Device Model Number: HACF0533
• Device Lot Number: FR115570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1