• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI INC CW-USLFS CYBERWAND FOOT SWITCH LITHOTRIPTOR, ELECTRO-HYDRAULIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GYRUS ACMI INC CW-USLFS CYBERWAND FOOT SWITCH LITHOTRIPTOR, ELECTRO-HYDRAULIC Back to Search Results
Model Number CW-USLFS
Device Problems No Device Output (1435); Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation determined that the reported issue was not able to be duplicated, however, a cut was noted on the cord that was wrapped with tape by the customer. Damaged cord was observed, however, the foot pedal was still found working. Due to damage cord, the foot pedal cannot be used and the unit itself is unrepairable. 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
It was reported that during an unspecified procedure the device transducer motor stopped working after being in use for 5 minutes. The user power cycled the device for a few minutes. The intended procedure was not completed. There were no other details provided regarding the event. There was no patient harm or injury reported. No user injury reported. This report is related to reports with patient identifiers: (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCW-USLFS CYBERWAND FOOT SWITCH
Type of DeviceLITHOTRIPTOR, ELECTRO-HYDRAULIC
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 Key11055593
MDR Text Key223459619
Report Number3011050570-2020-00191
Device Sequence Number1
Product Code FFK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K052135
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCW-USLFS
Device Lot NumberAC20169517
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 Received02/24/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-