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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 Foreign Body In Patient (2687)
Event Date 03/02/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone: (b)(6). (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.
 
Event Description
It was reported to boston scientific corporation that a rx needle knife xl was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022. During the procedure, while using the device, the needle detached from the catheter and fell into the patient. It was reported that there was no attempt made to retrieve the detached piece as the detached wire was small and it did not pose a risk. Additionally, the physician was expecting the patient to pass the detached needle. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event.
 
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Brand NameRX NEEDLE KNIFE XL
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 Key13890472
MDR Text Key288803982
Report Number3005099803-2022-01578
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUK
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
Type of Report Initial
Report Date 03/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00545840
Device Catalogue Number4584
Device Lot Number0027004974
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2021
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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