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

Model Number	HACF0533
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus for evaluation.The user discarded the device.Investigation is ongoing.This report will be supplemented accordingly following investigations.
Event or Problem Description
As reported, an invalid instrument error on two attachment handpieces hacf0533 with identical lot number fr119455 was reported.The user used a different lot number of the same instrument type without any more problem.The lot number used to complete the procedure was not provided.The procedure was able to start and complete without any more incident.There was no patient harm or injury reported due to the event.No user injury reported.This report is related to a report with patient identifier (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, 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.This lot number found no associated ncrs, reported scrap or recorded process deviations relating to the reported failure.The subject device did not return to olympus, device evaluation could not be performed.The observed failure is a known phenomenon resulting from possible incorrect assembly with the device and generator, or potentially not making sure the device is correctly set up prior to use.On page 2 of the device ifu (instruction for use), it states: position the device cord/cable to avoid contact with the patient and/or other leads.And on page 3: warning: insufficient generator output time or generator output level may not provide the operator with the desired level of coagulation.Olympus will continue to monitor complaints for this device.

• Brand Name: HALO PKS CUTTING FORCEPS,5MM/33CM
• Common Device Name: HALO PKS CUTTING FORCEPS,5MM/33CM
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12368615
• Report Number: 3011050570-2021-00095
• Device Sequence Number: 3821249
• Product Code: GEI
• UDI-Device Identifier: 00821925036390
• UDI-Public: 00821925036390
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: FR119455
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1