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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. ADJUSTABLE BIOPSY PORT SEAL Y-ADAPTER,5/PKG URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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MERIT MEDICAL SYSTEMS INC. ADJUSTABLE BIOPSY PORT SEAL Y-ADAPTER,5/PKG URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number BPS-Y
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing. If additional information becomes available following device evaluation, a supplemental report will be filed.
 
Event Description
As reported, the packaging of the adjustable biopsy port seal y-adapter contained a hair. There was no patient involvement during this event.
 
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Brand NameADJUSTABLE BIOPSY PORT SEAL Y-ADAPTER,5/PKG
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 west merit parkway
south jordan UT 84095
Manufacturer Contact
kenneth pittman
118 turnpike road
southborough, MA 01772
9013785969
MDR Report Key11317586
MDR Text Key242061033
Report Number3003790304-2021-00030
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K012758
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberBPS-Y
Device Lot NumberK1821136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/03/2021
Was Device Evaluated by Manufacturer? Yes
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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