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

Model Number	CD-B610LA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In speaking with olympus technical assistance center (tac), the olympus sales representative reported the customer discarded both the probe and packaging, without documenting the lot number.The rep had indicated the possibility the probe broke as a result of it being handled roughly.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer¿s olympus sales representative reported to olympus technical assistance center (tac) on behalf of the customer, the 10fr coax hemostatic probe broke off while withdrawing it during an unknown therapeutic procedure.At the time of the event, the elevator was in the up position.There were no reports of patient injury associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The observed failure could not be confirmed as the device did not return for evaluation and inspection, however it is important to note the potential rough handling.This observed failure is a known phenomenon likely resulting from mishandling of device in terms of rough force and probe tip misalignment.The following is stated in the instructions (ifu) for use which may prevent the event: "keep the device tip in sight during use.Inadvertent activation or movement of the device outside the field of vision may result in patient injury."; "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 the field performance of this device.

• Brand Name: 10FR COAX HEMOSTATIC PROBE
• Common Device Name: HEMOSTATIC PROBE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 4848965250
• MDR Report Key: 13742088
• Report Number: 3011050570-2022-00025
• Device Sequence Number: 4522092
• Product Code: KNS
• UDI-Device Identifier: 00821925039469
• UDI-Public: 00821925039469
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

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-B610LA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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