Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

BOSTON SCIENTIFIC CORPORATION LITHOVUE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number 791-360
Device Problems No Display/Image (1183); Appropriate Term/Code Not Available (3191)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
The exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.However, it was reported the device was not used past its expiry date.(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a lithovue flexscope was used in a transurethral ureteral stone removal procedure.According to the complainant, during the procedure, the lithovue flexscope would not display an image.When the scope was disconnected and re-plugged in the image was restored.Then the image disappeared again and procedure was discontinued.The procedure was cancelled due to this event.There was no serious injury/adverse effect to patient as a result of the event.
 
Event Description
It was reported to boston scientific corporation that a lithovue flexscope was used in a transurethral ureteral stone removal procedure.According to the complainant, during the procedure, the lithovue flexscope would not display an image.When the scope was disconnected and re-plugged in the image was restored.Then the image disappeared again and procedure was discontinued.The procedure was cancelled due to this event.There was no serious injury/adverse effect to patient as a result of the event.
 
Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date (b)(6)2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.However, it was reported the device was not used past its expiry date.Block h10: device problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation results the returned lithovue flexscope was analyzed, and a visual evaluation noted that there were no issues noted with the umbilicus cord or plug.Functional testing of the device found full articulation in the doth directions.The working channel was tested with a syringe of air and found no air leak.The distal tip, shaft, and pcba were in good condition.The reported event of no image was not confirmed.Based on product analysis being unable to replicate the reported display failure, the investigation conclusion code selected is no problem detected, which indicates the device complaint or problem cannot be confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LITHOVUE
Type of Device
URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11015456
MDR Text Key222059536
Report Number3005099803-2020-06016
Device Sequence Number1
Product Code FGB
UDI-Device Identifier08714729874812
UDI-Public08714729874812
Combination Product (y/n)N
PMA/PMN Number
K153049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number791-360
Device Catalogue Number791-360
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Date Manufacturer Received01/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-