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

Model Number	CD-B622LA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
An olympus representative reported to olympus on behalf of the customer that after the probe was removed from the scope, the nurse used gauze to clean the tip, the tip fell off on the trolley of the 7fr fixedpin hemostatic probe.The reported issue occurred at the end of the therapeutic sampling procedure.The procedure was completed with another similar device.There was no delay or patient harm, or impact associated with the reported event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Correction to e3.The returned device was inspected, and the complaint was confirmed.The device was returned inside a large plastic bag with the original packaging.The device was removed from the bag and examined.The probe tip was broken off.The entire ceramic tip was broken off in one piece, the shaft of the device did not appear to have any damage.The probe was examined and it had some dried blood still on it.The device was not plugged into a generator for testing as the probe had completely fallen off the device.The probe tip falling off was able to be confirmed.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, it is likely the tip experienced unexpected torque or excessive force during the cleaning, causing the adhesive to weaken and resulting in the tip falling out.Olympus will continue to monitor field performance for this device.

• Brand Name: 7FR FIXEDPIN HEMOSTATIC PROBE
• Common Device Name: BICOAG BIPOLAR 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: 17656614
• Report Number: 3011050570-2023-00131
• Device Sequence Number: 17723260
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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: KR238756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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