MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068403930
Medical Device Problem Codes	Misfire (2532); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on february 5, 2020 that a flexiva 550 laser fiber was used in a transuretheral prostate enucleation in the prostate performed on (b)(6) 2020.According to the complainant, during the procedure, upon pressing down the foot pedal, an abnormal sound was heard.The blast shield was noted to be burnt and the fiber was also damaged.The procedure was completed with another flexiva 550 laser fiber.There was no serious injury nor adverse patient effects as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: problem code 2532 captures the reportable event of fiber misfire.Block h10: investigation results the returned flexiva 550 laser fiber was analyzed and a visual evaluation noted that it was returned in one piece.The fiber measured approximately 280.3 cm from the top of the connector to the tip.The exposed glass portion of the tip measured approximately 4 mm and appeared degraded.Fibers are consumable and meant to degrade.Examination under magnification revealed that the pattern on the fiber tip was consistent with normal degradation.Visual examination revealed that light cannot travel well to the fiber face within the sma connector to illuminate it fully, indicating that the fiber was broken within the connector.It was likely due to the fracture within the connector that the fiber connector would cause laser energy to escape.Visual inspection of the returned fiber connector face noted burn marks, likely a result of attempting to pass laser energy down the fiber with the break within the connector.No other issues with the device were noted.The reported event was confirmed.It is possible that laser energy was passed through a fiber with a fracture in the connector, which resulted in the reported damage to the equipment.The conclusion code selected for the complaint is unintended use error caused or contributed to event.This indicates that the interaction between the user and the device caused or contributed to the reported event.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 directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2020 that a flexiva 550 laser fiber was used in a transuretheral prostate enucleation in the prostate performed on (b)(6), 2020.According to the complainant, during the procedure, upon pressing down the foot pedal, an abnormal sound was heard.The blast shield was noted to be burnt and the fiber was also damaged.The procedure was completed with another flexiva 550 laser fiber.There was no serious injury nor adverse patient effects as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: FLEXIVA
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9773912
• Report Number: 3005099803-2020-00641
• Device Sequence Number: 11316658
• Product Code: GEX
• UDI-Device Identifier: 08714729808206
• UDI-Public: 08714729808206
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: 09/17/2022
• Device Model Number: M0068403930
• Device Catalogue Number: 840-393
• Device Lot Number: 0000008440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1