MAUDE Adverse Event Report: GYRUS ACMI, INC 7FR COAX HEMOSTATIC PROBE; UNIT, ELECTROSURGICAL, ENDOSCOPIC

Model Number	CD-B620LA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event description: "tip of probe broke off outside of patient." 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.Dhr review for this lot found no associated ncrs (nonconformance's), reported scrap or recorded process deviations relating to the reported failure.As the device is not set to return, a physical device inspection cannot be performed.As a result, the initial complaint can not be confirmed.However, the observed failure is a known phenomenon likely resulting from inadvertent movement of the device tip during activation.On page 3 of the device instructions for use (ifu) (p9100505-001_ah), it states: "keep the device tip in sight during use.Inadvertent activation or movement of the device outside the field of vision may result in patient injury." olympus will continue to monitor complaints for this device.
Event or Problem Description
As reported, tip of the bipolar probe broke, fell off outside patient.According to the reporter, it was used once, and when they were going to use it a second time they realized the tip had broken off outside the patient.Customer were able to use a second item to complete the procedure.There was no patient harm, no user injury reported due to the event.

• Brand Name: 7FR COAX HEMOSTATIC PROBE
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): GYRUS ACMI, INC; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15210745
• Report Number: 3005975494-2022-00027
• Device Sequence Number: 4729983
• Product Code: KNS
• UDI-Device Identifier: 00821925039483
• UDI-Public: 00821925039483
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/11/2022

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: KR207889
• Was Device Available for Evaluation?: No
• 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: 07/14/2022
• Initial Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• 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