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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2024
Event Type  malfunction  
Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of presence of foreign material on the device.
 
Event Description
It was reported to boston scientific corporation that an autotome rx 44 was unpacked on (b)(6) 2024.When the device was unpacked in the storage room, it was noticed that the device inside the packaging appeared to have residue on the catheter of the device.It was reported that the packaging was intact, and the sterile barrier was not compromised.There was no procedure involved and the device was not used in the patient.Note: one of the photos of the complaint device provided by the customer showed an unknown residue present on the device.
 
Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of presence of foreign material on the device.Block h10: the returned autotome rx 44 was analyzed, and a visual evaluation noted that the device had evidence of foreign material at several sections in the cutting wire lumen.Photo provided by the customer also shows evidence of foreign material.No other problems with the device were noted.The product analysis revealed that the device has evidence of foreign material at several sections in the cutting wire lumen.The device presented a corrosion process through the surface of the wire, except for the handle and the distal section.Based on all gathered information, the most probable root cause of this complaint is quality control deficiency.An investigation to address this problem is in progress.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
Event Description
It was reported to boston scientific corporation that an autotome rx 44 was unpacked on (b)(6) 2024.When the device was unpacked in the storage room, it was noticed that the device inside the packaging appeared to have residue on the catheter of the device.It was reported that the packaging was intact, and the sterile barrier was not compromised.There was no procedure involved and the device was not used in the patient.Note: one of the photos of the complaint device provided by the customer showed an unknown residue present on the device.
 
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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
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 Key19198937
MDR Text Key341302865
Report Number3005099803-2024-01829
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729444749
UDI-Public08714729444749
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00545170
Device Catalogue Number4517
Device Lot Number0033280747
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/01/2024
Initial Date FDA Received04/27/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/24/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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