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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 Edema (1820)
Event Date 11/13/2020
Event Type  Injury  
Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. (b)(4). The device has been received for analysis; however, the analysis has not yet been completed. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020. According to the complainant, during the procedure, the blade of the knife came off when pre incision was performed. As a result, an edema occurred on the papilla and the resection range became wider. The blade of the knife was removed using a biopsy forceps. Preventive placement of a pancreatic duct stent was performed due to the patient's history of pancreatitis. The procedure was completed with a different device. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
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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 Key10946220
MDR Text Key219523062
Report Number3005099803-2020-05878
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K973826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/12/2022
Device Model NumberM00545840
Device Catalogue Number4584
Device Lot Number0025508116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/04/2020 Patient Sequence Number: 1
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