MAUDE Adverse Event Report: GYRUS ACMI, INC. 10FR COAX HEMOSTATIC PROBE

Model Number	CD-B610LA
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4 exact weight is 75.8 kg.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 during a therapeutic esophagogastroduodenoscopy (egd) the tip of the hemostatic probe broke off and lodged inside the scope channel.The user pushed it out and it fell inside the patient's stomach.The fallen piece was not retrieved.The procedure was prolonged a few minutes and completed with another manufacturer's device.There was no harm to the patient reported.No medical intervention was required.The patient's current condition is reported as "stable".
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved 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, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported during a therapeutic esophagogastroduodenoscopy (egd) the tip of the hemostatic probe broke off and lodged inside the scope channel.The user pushed it out and it fell inside the patient's stomach.The fallen piece was not retrieved.The procedure was prolonged a few minutes and completed with another manufacturer's device.There was no harm to the patient reported.No medical intervention was required.The patient's current condition is reported as "stable".

• Brand Name: 10FR COAX HEMOSTATIC PROBE
• Common Device Name: 10FR COAX HEMOSTATIC 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: 19567573
• Report Number: 3011050570-2024-10169
• Device Sequence Number: 6973911
• Product Code: KNS
• UDI-Device Identifier: 00821925039469
• UDI-Public: 00821925039469
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CD-B610LA
• Device Lot Number: KR382611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2024
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 76 KG