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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX NEEDLE KNIFE XL; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION RX NEEDLE KNIFE XL; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00545840
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an rx needle knife xl was used in the duodenum and sphincter of oddi during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.During the procedure, the rx needle knife xl was inserted through the endoscope.When the physician asked to extend the needle, nothing came out.The device was removed from the scope and when it was tried again to extend the needle, it was noticed that there was no needle present as the device had no needle at all.It was reported that there was no visible damage noted on the device.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.(b)(4).The complainant indicated that the device is not available for return; 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 Name
RX NEEDLE KNIFE XL
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 Key14091323
MDR Text Key289261168
Report Number3005099803-2022-01946
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729283799
UDI-Public08714729283799
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K973826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/12/2022
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 Expiration Date11/26/2023
Device Model NumberM00545840
Device Catalogue Number4584
Device Lot Number0028456991
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/21/2022
Initial Date FDA Received04/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2021
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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