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

Model Number	0010-6110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during stapedectomy surgical procedure, the fiber tip broke and started firing from the side instead of the tip, charring (burn) the incus.The physician looked under the microscope and observed that the fiber was at about a 45 degree angle.The fiber was exchanged, and the procedure was completed with a second fiber.There were no further patient complications and no injury to the staff.The physician and the staff were wearing the safety glasses.It is unknown if treatment was administered to the patient due to the event.
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Visual examination with magnification identified that the fiber tip was fractured and the fiber body was bent.Based on the fiber cap fracture, the reported fiber tip break was confirmed.A review of the product labeling determined that the product instructions for use (ifu) includes appropriate warnings for the reported and observed issues.It is likely that during use of the fiber there may have been inadvertent tissue contact and excessive manipulation or bending applied to the fiber, resulting in the fiber tip fracture and bent of the fiber body.Based on the analysis results, an evaluation conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
Event or Problem Description
It was reported that during stapedectomy surgical procedure, the fiber tip broke and started firing from the side instead of the tip, charring (burn) the incus.The physician looked under the microscope and observed that the fiber was at about a 45 degree angle.The fiber was exchanged, and the procedure was completed with a second fiber.There were no further patient complications and no injury to the staff.The physician and the staff were wearing the safety glasses.It is unknown if treatment was administered to the patient due to the event.

• Brand Name: ACCUSTAT
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10886410
• Report Number: 2937094-2020-00999
• Device Sequence Number: 19654389
• Product Code: GEX
• UDI-Device Identifier: 00878953000121
• UDI-Public: 00878953000121
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K924644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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: 04/30/2022
• Device Model Number: 0010-6110
• Device Catalogue Number: 0010-6110
• Device Lot Number: 0023718633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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