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U.S. Department of Health and Human Services

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

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GYRUS ACMI, INC 10FR COAX HEMOSTATIC PROBE Back to Search Results
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.
 
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Brand Name10FR COAX HEMOSTATIC PROBE
Type of DeviceHEMOSTATIC 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 Key13742088
MDR Text Key293080773
Report Number3011050570-2022-00025
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123319
Number of Events Reported1
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 Received03/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCD-B610LA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/23/2022
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

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