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

Model Number CD-B610LA

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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.

• Brand Name: 10FR COAX HEMOSTATIC PROBE
• Type of Device: 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
• MDR Text Key: 293080773
• Report Number: 3011050570-2022-00025
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CD-B610LA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial