MAUDE Adverse Event Report: GYRUS ACMI, INC 7FR COAX HEMOSTATIC PROBE

Model Number	CD-B620LA
Medical Device Problem Codes	Energy Output Problem (1431); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned for evaluation, the user facility discarded the device.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported during an unspecified procedure, when the device was activated, there was no output.The user connected a second like device and the unit work normally.There was no patient harm or injury reported associated on this reported event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction.Corrected initial reporters information to 'non-healthcare professional'.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, no output from the device was likely from a possible interference with the frequency or potential disconnect between components.The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user¿s experience cannot be determined at this time.The following is included in the instructions for use: "interference produced by the operation of high frequency surgical equipment may influence the operation of other electrical equipment adversely.Refer to the generator user manual." olympus will continue to monitor field performance for this device.

• Brand Name: 7FR COAX HEMOSTATIC PROBE
• Common Device Name: 7FR COAX HEMOSTATIC PROBE
• 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: 12939212
• Report Number: 3011050570-2021-00131
• Device Sequence Number: 4962802
• Product Code: KNS
• UDI-Device Identifier: 00821925039483
• UDI-Public: 00821925039483
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123319
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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: CD-B620LA
• Device Lot Number: KR141111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2021
• 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