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

Model Number	S-LLF273TG
Medical Device Problem Code	Defective Device (2588)
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
The device history record confirmed that the devices met all material, assembly and performance specifications.Analysis of the device revealed the fiber distal tip is fractured.The total length of the fiber is 11 feet and 10.25 inches, connector included in over-all length.The fiber was tested with hene laser fixture, aim beam is visible at the distal tip.There are no signs of breakage along the length of the fiber and at the connector.Dark discoloration was noted near fiber tip within blue jacket.Based on the information currently available, the cause of the observed device damage cannot be established.
Event or Problem Description
It was reported that during a procedure the sureflex fiber was defective after a half minute at 5w 5hz.There was no clinical consequences to the patient.Procedure was completed with another fiber.

• Brand Name: SUREFLEX FIBERS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 150 baytech drive; san jose CA 95134
• MDR Report Key: 9292303
• Report Number: 2937094-2019-61487
• Device Sequence Number: 19340520
• Product Code: GEX
• UDI-Device Identifier: 00878953004839
• UDI-Public: 00878953004839
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K140679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2019

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: 09/27/2021
• Device Model Number: S-LLF273TG
• Device Catalogue Number: S-LLF273TG
• Device Lot Number: 0022714529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1