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

Model Number	0010-6110
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified the fiber tip was broken and the distal end was not returned.It is probable that there was excessive manipulation of fiber during the procedure, resulting in the observed damages to the fiber, including the tip detachment.Thus, confirming the reported allegations of the aiming beam not showing as usual.According to the device instructions for use (ifu), the fiber is a precision device.Damage to the fiber can result in the emission of uncontrolled laser energy.Do not excessively manipulate or bend the fiber.Before beginning with the surgical procedure, the accustat should be checked for damage during shipment.The accustat is a glass fiber and any damage to the jacket or fiber core will result in the emission of uncontrolled laser energy.Do not probe or attempt to retract tissue with the accustat.To do so may result in fiber breakage.Based on analysis results, the interaction between the user and device caused or contributed to the identified break.
Event or Problem Description
It was reported that while trying to test fire, the laser aiming beam was very high up and not showing through the tip as usual.A second fiber was used to complete the procedure with no clinical consequences to the patient.The fiber was returned for analysis and the testing conducted identified the fiber being broken, and the distal end was not returned.

• Brand Name: ACCUSTAT
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 14515109
• Report Number: 2124215-2022-18142
• Device Sequence Number: 5629393
• Product Code: GEX
• UDI-Device Identifier: 00878953000121
• UDI-Public: 00878953000121
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K924644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2022

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: 03/07/2022
• Device Model Number: 0010-6110
• Device Catalogue Number: 0010-6110
• Device Lot Number: 0023453068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown