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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 Problems Mechanical Problem (1384); Suction Failure (4039)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to olympus for evaluation. The user¿s complaint that there was no suction and no force to break the stone was not confirmed. The cause could not be determined. No further information was reported. A supplemental will be submitted if new information becomes available or the device is returned.
 
Event Description
The user facility reported that there was an issue with the device during a procedure. There was no suction and no force to break the stone. The user was able to replace the device and complete the procedure. There was no patient injury. No additional information was provided.
 
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Brand NameCYBERWAND PROBE SET,3/BOX
Type of DevicePROBE
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 Key10373379
MDR Text Key202951273
Report Number3011050570-2020-00029
Device Sequence Number1
Product Code FFK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCW-RBPBX
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/13/2020
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 Reuse

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