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

Model Number	S-LLF273TG
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Actual event date is unknown.Analysis of the device revealed that the fiber distal tip was fractured.The total length of the fiber is 12 feet and 1.5 inches, connector included in over-all length.The fiber was tested with hene laser fixture, aim beam is visible at the distal tip.There were 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 analysis results, an evaluation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
The fiber was received without information.Analysis of the device found that the fiber distal tip was fractured.There was no patient outcome information available.
Additional Manufacturer Narrative
Actual event date is unknown.The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Analysis of the device revealed that the fiber distal tip was fractured.The total length of the fiber is 12 feet and 1.5 inches, connector included in over-all length.The fiber was tested with hene laser fixture, aim beam is visible at the distal tip.There were 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 analysis results, an evaluation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
The fiber was received without information.Analysis of the device found that the fiber distal tip was fractured.There was no patient outcome information available.

• Brand Name: SUREFLEX FIBERS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• MDR Report Key: 9258062
• Report Number: 2937094-2019-61455
• Device Sequence Number: 3934700
• Product Code: GEX
• UDI-Device Identifier: 00878953004839
• UDI-Public: 00878953004839
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K140679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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: 08/29/2021
• Device Model Number: S-LLF273TG
• Device Catalogue Number: S-LLF273TG
• Device Lot Number: 0022582374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Received by Manufacturer: 10/26/2019
• Supplement Date Received by Manufacturer: 10/26/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1