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

Model Number	HACF0533
Medical Device Problem Codes	Energy Output Problem (1431); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the user reported having an intermittent activation issue with the device.Sometimes when presses the button on the handpiece to activate the coagulation, there would be no energy coming out.The user switches over to another halo handpiece from the same box to continue with the procedure.The intended procedure was completed.The issue occurred during a laparoscopic bilateral salpingectomy.There was no patient impact or harm on this reported event.No user injury was reported.
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and legal manufacturer's final investigation.The customer returned the subject device to olympus for evaluation due to "intermittent activation issue".The device was evaluated by an olympus estimation technician.During the evaluation the user's complaint could not be replicated.The device passed all functional testing and all specifications were found to be within tolerance.There were no abnormalities noted.The subject device functioned as intended.Based on the evaluation, olympus was unable to replicate the user's experience during testing.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 cause of the event could not be identified.Since the complaint could not be confirmed, the observed failure is a known phenomenon likely resulting in a lack of tissue grasped or possibly a low generator output level.The following directions are in the instructions for use which can prevent the event: "both coagulating surfaces should be in equal contact with tissue for optimum coagulation." olympus will continue to monitor the field performance of this device.

• Brand Name: HALO PKS CUTTING FORCEPS,5MM/33CM
• Common Device Name: HALO PKS CUTTING FORCEPS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 9013785969
• MDR Report Key: 12712976
• Report Number: 3011050570-2021-00113
• Device Sequence Number: 4774936
• Product Code: GEI
• UDI-Device Identifier: 00821925036390
• UDI-Public: 00821925036390
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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: HACF0533
• Device Lot Number: FR101646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown