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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - SPENCER LITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number M0067913500
Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device has been received for analysis without the tray, inside an opened pouch. The box was not returned. The outside of the pouch appeared to have betadine residue. The clear side of the pouch had been written on with marker, and circled. Within the circle are two puncture hole through the clear side of the pouch, each between 0. 5-1cm in length. The deformation of the material suggests that the punctured holes were made from the external side of the pouch material and into the pouch and it is likely that the pouch was somehow punctured during unpacking/preparation. This confirms the complaint. Damage was caused to the device without direct patient contact. Therefore, a review and analysis of all available information indicated that the most probable root cause is handling damage. 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 on (b)(6) 2018 that a lithovue single-use digital flexible ureteroscope was opened to be used for a procedure. According to the complainant, during unpacking, there was a noticeable hole in the package. The product was not used for the procedure.
 
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Brand NameLITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
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 Key7695886
MDR Text Key114690717
Report Number3005099803-2018-02330
Device Sequence Number1
Product Code FGB
UDI-Device Identifier08714729874805
UDI-Public08714729874805
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 06/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/16/2020
Device Model NumberM0067913500
Device Catalogue Number791-350
Device Lot Number22135275
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2018
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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