MAUDE Adverse Event Report: GYRUS ACMI, INC. 7FR COAX HEMOSTATIC PROBE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE

Model Number	CD-B620LA
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	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the shaft of the device had two minor kinks and the probe at the distal end appeared to be falling off.The gray shaft near the probe appeared slightly discolored as if it was burned or twisted, which resulted in the inner wires being exposed.The inner wires appeared broken.The device was not plugged in for functional testing due to the broken wires.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
The customer reported the 7fr coax hemostatic probe failed out of the box and caused a spark when attempting to be used.The issue occurred during the middle of a therapeutic small bowel enteroscopy with hemostasis and ablation of lesions.The patient had a history of gastrointestinal bleeding and small bowel angioectasia identified on capsule endoscopy.A second gold probe was used to control the large avm that began to bleed with minimal manipulation.No medical intervention was required and no other devices were connected.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the tip broke off.The report is being submitted due to the defect found during evaluation.
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 root cause of the event could not be determined although it can be presumed it was due to the probe experiencing excessive stress causing kinks within the body stock or colliding with another object.Olympus will continue to monitor field performance for this device.

• Brand Name: 7FR COAX HEMOSTATIC PROBE
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
• 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: 17904522
• Report Number: 3011050570-2023-00151
• Device Sequence Number: 18032655
• Product Code: KNS
• UDI-Device Identifier: 00821925039483
• UDI-Public: 00821925039483
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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-B620LA
• Device Lot Number: KR111347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2021
• 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
• Patient Sex: Unknown