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

Model Number	M006R8403921
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: the returned flexiva id 365 laser fiber was analyzed, and a visual evaluation noted that the package included a foreign object.No other issues with the device were noted.The reported event was confirmed.It is likely that the foreign material was introduced to the packaging as part of the manufacturing process.The pouch is sealed at the supplier prior to shipment for sterilization.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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.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 id 365 laser fiber was opened for use for a greenlight cystoscopy procedure in the prostate performed on (b)(6) 2020.According to the complainant, during preparation, it was noted that there was a hair inside the package when it was inspected.The package was not opened, but the hair was visible from the outside.There was no visible damage on the packaging.The procedure was completed with another flexiva id 365 laser fiber.There were no patient complications reported as a result of this event.

• 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: 9884989
• Report Number: 3005099803-2020-01335
• Device Sequence Number: 16266605
• Product Code: GEX
• UDI-Device Identifier: 08714729963783
• UDI-Public: 08714729963783
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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: 10/15/2022
• Device Model Number: M006R8403921
• Device Catalogue Number: 69271
• Device Lot Number: 0000008578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1