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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRASOUND PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC

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BOSTON SCIENTIFIC CORPORATION ULTRASOUND PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC Back to Search Results
Model Number 840-717
Device Problems Break (1069); Material Deformation (2976); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/18/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a lithoclast ultrasound probe was used during a percutaneous nephrolithotomy procedure in the kidney performed on (b)(6) 2020. According to the complainant, during the procedure, the ultrasound probe broke and was unable to remove the broken probe from the handpiece. Nothing detached inside the patient. The procedure was cancelled due to this event. There was no serious injury/adverse effect to patient as a result of the event.
 
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Brand NameULTRASOUND PROBE
Type of DeviceLITHOTRIPTOR, ELECTRO-HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
ELECTRO MEDICAL SYSTEMS SA
ch. de la vuarpilliere 31
ch-1260
nyon, sz 1260
CH 1260
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key10658555
MDR Text Key219499511
Report Number3005099803-2020-04443
Device Sequence Number1
Product Code FFK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012445
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number840-717
Device Catalogue Number840-717
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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