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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH LITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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BOSTON SCIENTIFIC - MARLBOROUGH LITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number M0067913600
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/23/2018
Event Type  malfunction  
Manufacturer Narrative
The complainant indicated that the device has been 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. A review of the device history record (dhr) was performed; no anomalies were noted. A search of the complaint database revealed that no similar complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that a lithovue reverse deflection scope was used during a ureteroscopy procedure in the ureter performed on (b)(6) 2018. According to the complainant, during preparation, the box was opened and a punctured hole was found through the sterile package. The procedure was completed with a reusable scope. Reportedly, the touch pc was used successfully after this event. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
 
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Brand NameLITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
BOSTON SCIENTIFIC - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7408278
MDR Text Key105167770
Report Number3005099803-2018-01133
Device Sequence Number1
Product Code FGB
UDI-Device Identifier08714729874812
UDI-Public08714729874812
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
Report Date 03/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/19/2020
Device Model NumberM0067913600
Device Catalogue Number791-360
Device Lot Number21760833
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 Received03/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2018
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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