MAUDE Adverse Event Report: GYRUS ACMI L.P. 10FR COAX HEMOSTATIC PROBE

Model Number	CD-B610LA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation and follow up with the customer is being performed to confirm if the device will be returned.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the hemostatic probe's tip broke off.The issue was found during an unspecified procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Three attempts were performed to obtain additional information, but no response was received from the customer 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 root cause of the event could not be determined although it can be presumed that the event occurred due to excessive force being applied and/or over bending the tip, causing the sheathing on the distal end to snap.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to correct the previous h10 statement which should be "the device history record was unable to be reviewed for this device.".
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: 10FR COAX HEMOSTATIC PROBE
• Common Device Name: 10FR COAX HEMOSTATIC PROBE
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18383869
• Report Number: 3003790304-2023-00456
• Device Sequence Number: 19825442
• Product Code: KNS
• UDI-Device Identifier: 00821925039469
• UDI-Public: 00821925039469
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/20/2024

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-B610LA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: Not provided; 02/29/2024; 06/20/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/28/2024; 02/29/2024; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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