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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE SYSTEM WORKSTATION URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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BOSTON SCIENTIFIC CORPORATION LITHOVUE SYSTEM WORKSTATION URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number 801-000
Device Problems Failure to Power Up (1476); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a lithovue touch pc was attempted to be used on (b)(6) 2021. Touch pc could not power on, tried different socket and still would not power on. The procedure was cancelled due to this event. There were no patient complications reported as a result of this event.
 
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Brand NameLITHOVUE SYSTEM WORKSTATION
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue
attn: return products
st. paul MN 55112
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key12077039
MDR Text Key258705411
Report Number3005099803-2021-03071
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153049
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 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number801-000
Device Catalogue Number801-000
Device Lot NumberLV03342
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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