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

Model Number	M0068403930
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received but an evaluation has not yet been performed; therefore, a failure analysis is not available.If there is any further relevant information received, a supplemental mdr report will be filed.
Event or Problem Description
It was reported to boston scientific on (b)(6) 2020 that a flexiva 550 laser fiber was used during a holep procedure in the prostate performed on (b)(6) 2020.Reportedly, the laser unit was a lumenis vp 100w console with settings of 30 hz and 1.5 j.According to the complainant, the glass tip broke off inside the patient between lobes of the prostatic tissue.The bladder was morcellated and thoroughly washed out and the bladder, prostatic fossa and urethra was fully assessed at the end of the procedure to ensure that no fragments were remaining.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: device code 2907 represents the reportable event of tip detached.Block h10: the returned flexiva 550 laser fiber was analyzed, and a visual evaluation noted that the fiber was returned in one piece.The fiber measured approximately 279.9 cm from the top of the connector to the tip.No exposed glass tip remained on the device.Visual examination under magnification reveals that the fiber tip is fractured with a portion detached.The remainder of the distal tip was not returned.No other issues with the device were noted.The reported event was confirmed.The condition of the returned device confirms that the fiber tip detached, likely as a result of handling the device as it was unpacked or during the procedure when the device was introduced into the scope, and the device had no influence on the event.The conclusion code selected for the tip detachment is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on the 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 on (b)(6), 2020 that a flexiva 550 laser fiber was used during a holep procedure in the prostate performed on (b)(6), 2020.Reportedly, the laser unit was a lumenis vp 100w console with settings of 30 hz and 1.5 j.According to the complainant, the glass tip broke off inside the patient between lobes of the prostatic tissue.The bladder was morcellated and thoroughly washed out and the bladder, prostatic fossa and urethra was fully assessed at the end of the procedure to ensure that no fragments were remaining.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: FLEXIVA
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 9648862
• Report Number: 3005099803-2020-00176
• Device Sequence Number: 2767819
• Product Code: GEX
• UDI-Device Identifier: 08714729808206
• UDI-Public: 08714729808206
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2022
• Device Model Number: M0068403930
• Device Catalogue Number: 840-393
• Device Lot Number: 0000007857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1