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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION HYDRATOME RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00583050
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 11/13/2018
Event Type  malfunction  
Event Description
During sphincterotomy, sphincterotome cut wire and snapped while in place in the common bile duct. Equipment representative and the general surgeon called for consultations. Sphincterotome wire withdrawn from the common bile duct and procedure terminated. Doctor informed patients family of incident. Manufacturer response for unit, electrosurgical, endoscopic (with or without accessories), hydratome rx 44 (per site reporter). A complaint you called in today has been logged under (b)(4). Please use (b)(4) to facilitate the return of the device back to bsc. The account will receive 1 replacement and 1 return kit.
 
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Brand NameHYDRATOME 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 Key8119425
MDR Text Key128881576
Report Number8119425
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729755203
UDI-Public(01)08714729755203
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00583050
Device Catalogue NumberM00583050
Device Lot Number22421173
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/21/2018
Event Location Hospital
Date Report to Manufacturer11/30/2018
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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