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

Model Number	HACF0533
Medical Device Problem Codes	Output Problem (3005); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was received and evaluated.The device 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 and the shaft is straight.Cord is intact.There are dried tissues on jaw consistent with use.The jaw symmetry is balanced, and the jaw mesh is good.The jaw aperture measurement was taken inside the first teeth of the jaw, measured at.365¿¿ (standard is.300¿ +/-.100¿) which is acceptable.The jaws could grasp a tissue and lock into position.There are 2 narrow cracks on the insulation of the jaw legs, but the flare appeared to be normal.Functional testing was performed using a reference test generator and functional test found no intermittent problem was observed during activation.Based on the evaluation findings, the reported complaint was not confirmed.The device was returned as used, but functioning as designed.The dhr (device history record) 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.The possible cause of the reported complaint is likely that if forceps jaws come in contact with each other when the power is activated.On page 4 of the device ifu (instruction for use), it states: if forceps jaws come in contact with each other when the power is activated, instrument will short out.Olympus will continue to monitor complaints for this device.
Event or Problem Description
As reported, the user was using the hacf0533 during a bilateral laparoscopic salpingectomy procedure and the halo forceps were only working intermittently.The user used a second halo device to complete the procedure.There was no patient harm or injury reported due to the event.No user injury reported.

• 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
• MDR Report Key: 12509883
• Report Number: 3011050570-2021-00108
• Device Sequence Number: 19850647
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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: 08/26/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1