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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) RX NEEDLE KNIFE XL UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) RX NEEDLE KNIFE XL UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00545840
Device Problems Detachment of Device or Device Component (2907); Needle (3088)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

 
Event Description

It was reported to boston scientific corporation that a microknife rx 3l needle knife was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016. According to the complainant, during procedure, after cutting the ampulla, it was noticed that the needle knife was detached and embedded into the ampulla. They tried to retrieve the detached needle using a standard forceps but the needle was too small to retrieve. A spybite forceps was then used to remove the detached needle from the patient. Reportedly, the procedure was considered difficult, and the procedure was not completed. There were no reported patient complications due to this event. The patient's condition at the conclusion of the procedure was reported to be stable.

 
Manufacturer Narrative

Visual evaluation of the returned device found that the cutting wire was melted and blackened. In addition, the tome's extrusion was found melted at the distal tip. A functional analysis could not be performed due to the condition of the returned device. The complaint was consistent with the reported event of needle detached. It is most likely that a peak of voltage applied during the procedure which could cause the failures noted. Based on the device condition, the most probable root cause of this complaint is operational context since due to anatomical/procedural factors encountered during the procedure, performance was limited. A dhr (device history record) review was performed and no deviation was found. A search of the complaint database confirmed that no similar complaints exist for the specified batch. A labeling review was performed and there is no evidence that the device was not used in accordance with the labeling.

 
Event Description

It was reported to boston scientific corporation that a microknife rx 3l needle knife was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016. According to the complainant, during procedure, after cutting the ampulla, it was noticed that the needle knife was detached and embedded into the ampulla. They tried to retrieve the detached needle using a standard forceps but the needle was too small to retrieve. A spybite forceps was then used to remove the detached needle from the patient. Reportedly, the procedure was considered difficult, and the procedure was not completed. There were no reported patient complications due to this event. The patient's condition at the conclusion of the procedure was reported to be stable.

 
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Brand NameRX NEEDLE KNIFE XL
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key6202070
MDR Text Key63196734
Report Number3005099803-2016-03903
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeGB
PMA/PMN NumberK973826
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 12/01/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/24/2018
Device MODEL NumberM00545840
Device Catalogue Number4584
Device LOT Number19386252
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/23/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/24/2016
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: 12/23/2016 Patient Sequence Number: 1
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