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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 39 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION TRUETOME 39 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00584190
Device Problems Break (1069); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a truetome 39 was used in the ampulla during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2022. During the procedure, "the cutting wire disconnected. " it was reported that no part of the cutting wire detached and fell into the patient. Additionally, the ampulla was not tortuous or cancerous. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. A photo of the complaint device outside the patient was provided by the customer and shows the wire was broken and kinked.
 
Manufacturer Narrative
(b)(4). The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
 
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Brand NameTRUETOME 39
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 Key14218381
MDR Text Key290151108
Report Number3005099803-2022-02247
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K122203
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00584190
Device Catalogue Number8419
Device Lot Number0028068925
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2021
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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