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

Model Number	S-LLF200TG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure the fiber burnt the staff members hand.User outcome in response to the reported event was not provided and it was indicated that no further information is available.
Event or Problem Description
It was reported that during a procedure the fiber burnt the staff members hand.User outcome in response to the reported event was not provided and it was indicated that no further information is available.
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Analysis of the device revealed the fiber is broken in two pieces.The returned fiber is 7ft.And 1in., connector included in overall length.The distal portion of the fiber was not returned.The distal tip end of the fiber is fractured.The fiber was tested with hene laser fixture, aim beam is visible at the fiber tip end.Based on the observed fiber fracture at distal tip, an evaluation conclusion code of cause not established was assigned to this investigation.

• 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: 8189112
• Report Number: 2937094-2018-60250
• Device Sequence Number: 1900942
• Product Code: GEX
• UDI-Device Identifier: 00878953004822
• UDI-Public: 00878953004822
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: S-LLF200TG
• Device Catalogue Number: S-LLF200TG
• Device Lot Number: 0022063167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other