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

Model Number	S-LLF200TG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while using a surflex fiber, the fiber broke causing an injury to the surgeons right index finger.Gloves removed, betadine applied, and new gloves were used by the surgeon.The procedure was completed using another fiber; there was no harm to the patient.No further medical attention was required for the physicians finger.
Event or Problem Description
It was reported that the fiber broke during use causing a welt or burn on the surgeons right index finger.The gloves were removed and betadine and a bandaid applied.The surgeon put on new gloves and the procedure was completed with a second fiber.There was no clinical consequence to the patient and the surgeon required no additional treatment.
Additional Manufacturer Narrative
Adverse event/product problem corrected to reflect reported event.
Event or Problem Description
It was reported that the fiber broke during use causing a welt or burn on the surgeons right index finger.The gloves were removed and betadine and a bandaid applied.The surgeon put on new gloves and the procedure was completed with a second fiber.There was no clinical consequence to the patient and the surgeon required no additional treatment.
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The device was not available for analysis and therefore the probable cause of the reported incident cannot be determined, therefore an evaluation conclusion code of cause not established as assigned to this event.

• 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: 8945698
• Report Number: 2937094-2019-61152
• Device Sequence Number: 11373640
• 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: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2021
• Device Model Number: S-LLF200TG
• Device Catalogue Number: S-LLF200TG
• Device Lot Number: 0022523853
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 02/20/2020
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 10/03/2019; 03/15/2020
• 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