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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00545180
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2020
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, (b)(6) 2020.(b)(4).The device has not been received for analysis.Upon receipt and 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 an autotome rx 44 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, during the procedure, the cutting wire broke.Nothing detached and fell into the patient.The procedure was completed with another autotome rx 44 device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
 
Event Description
It was reported to boston scientific corporation that an autotome rx 44 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, during the procedure, the cutting wire broke.Nothing detached and fell into the patient.The procedure was completed with another autotome rx 44 device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
 
Manufacturer Narrative
Correction: e3, g1, g3 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, (b)(6)2020.Block h6: device code 1069 captures the reportable event of wire break.Block h10: the returned autotome rx 44 was analyzed, and a visual evaluation noted that the cutting wire was detached, bent and blackened.Additionally, the working length was found torn from the end of the c-channel to distal tip.No other issues with the device were noted.The reported event was confirmed.The failure found could had been generated by a peak of voltage or if the device was not in contact with the tissue when it was energized; also, working length torn in c-channel section could be caused by the manipulation of the device or by the interaction with other devices or scope.Therefore, the most probable cause of this complaint is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
 
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Brand Name
AUTOTOME RX 44
Type of Device
UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10075797
MDR Text Key193974881
Report Number3005099803-2020-01975
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729444756
UDI-Public08714729444756
Combination Product (y/n)N
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/23/2022
Device Model NumberM00545180
Device Catalogue Number4518
Device Lot Number0024484578
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2020
Date Manufacturer Received06/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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