MAUDE Adverse Event Report: GYRUS ACMI, INC. 7FR FIXEDPIN HEMOSTATIC PROBE; HEMOSTASIS PROBE

Model Number	CD-B622LA
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E2/e3: information was asked but unknown, in regard to occupation of the initial reporter or whether they are a healthcare professional.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the subject device's ceramic tip was dislodged.The event occurred during a therapeutic gastrointestinal bleeding procedure, and it was completed using a similar device.There were no reports of patient harm.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation and updates to fields d8, d9, g1, and h4.The device was returned to olympus for inspection and the reported failure was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: a component failure of the probe.The cause of the molten shape at the distal end of the flush port could not be determined.The event can be prevented by following the instructions for use which state: 10 preparation, inspection and operation.10.3 operation- warning: do not force the distal end of the insertion portion against body cavity tissue.Always operate the generator at the minimum output level and for the minimum time necessary to successfully complete the procedure.Insufficient generator output time or generator output level may not provide the operator with the desired level of coagulation.Excessive generator output time or generator output level may result in burning of tissue not intended for coagulation.If the output is set too high, tissue may dry out rapidly, causing sticking, and hemostasis may be compromised.Olympus will continue to monitor field performance for this device.

• Brand Name: 7FR FIXEDPIN HEMOSTATIC PROBE
• Common Device Name: HEMOSTASIS PROBE
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19588529
• Report Number: 3011050570-2024-10186
• Device Sequence Number: 20680627
• Product Code: KNS
• UDI-Device Identifier: 00821925039452
• UDI-Public: 00821925039452
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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-B622LA
• Device Lot Number: KR275872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown