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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI INC CYBERWAND PROBE SET,3/BOX

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GYRUS ACMI INC CYBERWAND PROBE SET,3/BOX Back to Search Results
Model Number CW-RBPBX
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device has not yet been received for evaluation. The cause of the issue cannot be determined at this time. If additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported that the probe broke at the proximal end of the instrument during a therapeutic procedure. No known broken pieces fell into the patient. Another similar device probe was used and the intended procedure was completed. No patient harm or injury reported due to the event. No user injury reported.
 
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Brand NameCYBERWAND PROBE SET,3/BOX
Type of DeviceCYBERWAND PROBE SET,3/BOX
Manufacturer (Section D)
GYRUS ACMI INC
136 turnpike road
southborough PA 01772
Manufacturer Contact
kenneth pittman
9600 louisiana avenue north
brooklyn park, MA 55445
9013785969
MDR Report Key10727042
MDR Text Key213200229
Report Number3011050570-2020-00125
Device Sequence Number1
Product Code FFK
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K120303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCW-RBPBX
Device Lot NumberW1901135
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2019
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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