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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OTU MEDICAL DISPOSABLE URETEROSCOPE
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OTU MEDICAL DISPOSABLE URETEROSCOPE Back to Search Results
Catalog Number BDSD01
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/19/2022
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that two flexible ureteroscopes had been used on the same patient.The first one was damaged by the laser fiber due to the limited flexion of the disposable scope compared to the reusable ureteroscope.It was stated that has been a limitation with 2 lower pole stones recently.The other patient had to come back and have an extra shock wave lithotripsy performed.
 
Manufacturer Narrative
The reported event is inconclusive because no sample was returned for evaluation.A potential root cause for this event could be inadequate training.The device was used for treatment purposes.It is unknown if the device had met all relevant specifications or resulted in the reported event.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "¿ bd single-use digital flexible ureteroscope can only be used in conjunction with bd image system.Connection to other 3rd party devices may cause device damage or operator injury." "¿ only physicians with adequate ureteroscopic training should perform procedures with the ureteroscope." "¿ bd recommends a 200-micron laser fiber for maximum deflection and access to the kidney.A larger fiber may break and be accidentally fired inside the working channel, damaging the endoscope." h11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the device was not returned.
 
Event Description
It was reported that two flexible ureteroscopes had been used on the same patient.The first one was damaged by the laser fiber due to the limited flexion of the disposable scope compared to the reusable ureteroscope.It was stated that has been a limitation with 2 lower pole stones recently.The other patient had to come back and have an extra shock wave lithotripsy performed.Per notification from investigator on 23aug2022, it was found that the working channel was observed to be pierced by the working channel during sample evaluation.
 
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Brand Name
DISPOSABLE URETEROSCOPE
Type of Device
DISPOSABLE URETEROSCOPE
Manufacturer (Section D)
OTU MEDICAL
2847a whipple road
union city CA 94587
MDR Report Key14734549
MDR Text Key294383303
Report Number1018233-2022-04728
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181977
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberBDSD01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/19/2022
Event Location Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/17/2022
Supplement Dates Manufacturer Received10/04/2022
Supplement Dates FDA Received10/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
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