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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DREAMTOME RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION DREAMTOME RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00584040
Device Problems Port (495); Material Twisted/Bent (2981); Tip (3123); Switch, Push Button (3154); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2019
Event Type  Malfunction  
Event Description

Dreamtome tip coiled up inside the biopsy port button and would not go down the biopsy channel on the ercp scope. New dreamtome utilized with no problem. Manufacturer response for ercp wire, dreamtome rx 44 (per site reporter). Equipment failure reported to endosurgery complaints. Equipment sent back.

 
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Brand NameDREAMTOME RX 44
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
MDR Report Key8950074
MDR Text Key156127938
Report Number8950074
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/31/2019,07/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM00584040
Device Catalogue NumberM00584040
Device LOT Number23155613
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/31/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/31/2019
Event Location Hospital
Date Report TO Manufacturer08/30/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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