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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 M00545170
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an autotome rx 44 was intended to be used in the papilla in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022. During unpacking outside the patient, it was noticed that the cutting wire was broken. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. The patient's condition was reported to be stable.
 
Manufacturer Narrative
(b)(4). The device has not been received for analysis. Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
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Brand NameAUTOTOME RX 44
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key14686751
MDR Text Key299695043
Report Number3005099803-2022-03279
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729444749
UDI-Public08714729444749
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00545170
Device Catalogue Number4517
Device Lot Number0027828040
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2021
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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