MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME JAG 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00583140
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(date of event): the exact date of the event is unknown.The provided event date (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The returned truetome jag 44 was analyzed, and a visual evaluation noted that the cutting wire was broken, blackened, and bent, consistent with the findings when the device was observed under magnification.A functional evaluation was not performed due to the condition of the device (broken cutting wire).No other problems with the device were noted.The product analysis revealed that the cutting wire was broken.Upon analysis, it was found that the cutting wire was broken, blackened, and bent.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been caused if the cutting wire was preactivated before use which may cause premature cutting wire fatigue and may compromise the cutting wire's integrity.Not verifying that the cutting wire if it has exited the endoscope while electrical current is applied, and not maintaining direct and constant contact with tissue when applying electrocautery current could also contribute to wire breakage, as well as excessive power which may damage the integrity of cutting wire, according to the instructions for use.It was also found that the cutting wire was bent which could have been generated when the device was withdrawn from the procedure.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
Initially it was reported that there was an unknown event with a truetome jag 44 device on an unknown date.The device was returned, and preliminary investigation results revealed that there is a break in the cutting wire.This event has now been deemed reportable and full investigation results will follow in a final report.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: TRUETOME JAG 44
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12705002
• Report Number: 3005099803-2021-05449
• Device Sequence Number: 4538122
• Product Code: KNS
• UDI-Device Identifier: 08714729858683
• UDI-Public: 08714729858683
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2023
• Device Model Number: M00583140
• Device Catalogue Number: 8314
• Device Lot Number: 0027101315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/27/2021
• Patient Sequence Number: 1