MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA (TM) ID HIGH POWER SINGLE-USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M006R8403931
Medical Device Problem Codes	Break (1069); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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 or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a flexiva id 550 laser fiber was used in a prostate nucleation procedure in the prostate performed on (b)(6) 2019.According to the complainant, during the procedure, the laser fiber was broken and laser energy escaped causing to burn two holes on the drape.The procedure was completed with another flexiva id 550 laser fiber.There was no serious injury nor adverse patient effects as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on may 2, 2019 that a flexiva id 550 laser fiber was used in a prostate nucleation procedure in the prostate performed on (b)(6)2019.According to the complainant, during the procedure, the laser fiber was broken and laser energy escaped causing to burn two holes on the drape.The procedure was completed with another flexiva id 550 laser fiber.There was no serious injury nor adverse patient effects as a result of this event.
Additional Manufacturer Narrative
Block e4: maude report received (user facility) number: mw5086501.Block h6: problem codes 1069 and 2532 captures the reportable event of fiber broke and misfired.Block h10: investigation result one flexiva id 550 laser fiber was returned broken in three pieces.The first piece measured approximately 83.4 cm from the top of the connector to the break.The second piece measured approximately 114.9 cm from the break to the break.The third piece measured approximately 71.9 cm from the break to the break.The remainder of the fiber, including the distal tip, was not returned.Visual inspection of the returned fiber noted burn marks on the fiber jacketing, likely a result of the fiber break occurring during use, resulting in a misfire.The condition of the returned device confirms that the fiber was broken and misfired.Review and analysis of all available information indicated that the root cause is manufacturing deficiency.A complaint with a cause of manufacturing deficiency indicates that the problems were traced to the manufacturing process.An investigation was completed to address this issue which identified the most probable root cause of the fiber break as handling during the manufacturing process caused by the supplier manufacturer.A dhr (device history record) review was performed and the device met all manufacturing specifications.

• Brand Name: FLEXIVA (TM) ID HIGH POWER SINGLE-USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8633567
• Report Number: 3005099803-2019-02650
• Device Sequence Number: 13938333
• Product Code: GEX
• UDI-Device Identifier: 08714729963806
• UDI-Public: 08714729963806
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: 03/07/2022
• Device Model Number: M006R8403931
• Device Catalogue Number: 69271
• Device Lot Number: 0000007413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1