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

Model Number	CD-B612LA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, while inserting the probe in the biopsy channel user felt resistance and when withdraw the probe came apart.The distal part tip of the device broke.The issue found during an unspecified procedure.No pieces fell into the patient.The procedure was completed with a different device.There was no patient harm or injury reported due to the event.No user injury reported.
Additional Manufacturer Narrative
The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Olympus performed a visual inspection on the as is received condition of the device; observed near the hemostasis tip the gray tubing was damaged and torn.There were two blue wires which were exposed due to the gray tubing being damaged and torn.The area which was damaged was examined under a microscope and olympus verified that the torn area had uneven edges.Olympus further inspected the female luer as well as the electrical connector and there were no signs of physical damage or discrepancies.There was a portion of the gray tubing which had multiple heavy kinks.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 most possible cause of the tip being damaged could likely be attributed to mishandling and using the device through ranges of resistance and stresses that are excessive as there a signs of heavy kinks in the gray tubing.The following is stated in the instructions for use which can prevent the event: "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." olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be 21-dec-2021.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• Brand Name: 10FR FIXEDPIN HEMOSTATIC PROBE
• Common Device Name: 10FR FIXEDPIN HEMOSTATIC PROBE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 9013785969
• MDR Report Key: 13402588
• Report Number: 3011050570-2022-00010
• Device Sequence Number: 16569635
• Product Code: KNS
• UDI-Device Identifier: 00821925039476
• UDI-Public: 00821925039476
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2022

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-B612LA
• Device Lot Number: KR109222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• 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: 01/07/2022
• Supplement Date Received by Manufacturer: 02/17/2022; 11/08/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 02/17/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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: MEDICAL TWEEZERS.
• Patient Sex: Unknown