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	12/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that while using the 10fr coax hemostatic probe, the distal end of the probe broke inside the endoscope, while being used in the patient.The issue occurred during the emergency therapeutic procedure (arrest of bleeding), there was no delay, and the procedure was completed with a similar device.There was no patient harm associated with the event.
Additional Manufacturer Narrative
The device was returned, and the evaluation is currently pending.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 customer complaint of device breaking at the distal tip has been confirmed.The distal end of the device was found to be broken and showing the inner wires.However, the distal end did not fully break off and all parts of the device appear to have been returned.The likely root cause of the breakage was too much force being applied or overbending the tip, which caused the sheathing on the distal end to snap.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: "do not use the device if resistance to insertion is encountered.Reduce the angle or lower the forceps elevator of the endoscope until the device passes smoothly; do not advance or extend the device abruptly." olympus will continue to monitor field performance 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 3011050570.

• 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: 16098645
• Report Number: 3003790304-2023-00003
• Device Sequence Number: 6233803
• Product Code: KNS
• UDI-Device Identifier: 00821925039469
• UDI-Public: 00821925039469
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2024

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: KR130782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2022
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 03/16/2023; 06/19/2024
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 04/14/2023; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE
• Patient Sex: Unknown