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

Model Number	0010-6110
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported mechanical issue cannot be established as the product is not available for analysis.Device history record (dhr): the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could not be performed.The reported device performance allegation cannot be confirmed.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that during the procedure the fiber tip broke off.A new fiber was used to complete the procedure.The procedure was completed with no reported clinical consequences.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the reported event of fiber tip broke off was confirmed as analysis identified that the glass tip of the fiber was broken and detached.It is probable that the glass cap detachment resulted from excessive manipulation during use.Additionally, the bend in the metal tip provides further evidence of excessive force and manipulation.Device history record: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the product was returned for analysis to our post market quality assurance laboratory.Visual analysis under a microscope identified the glass tip of the fiber was broken and detached.It was observed that the metal tip was bent.Labeling review: a review of device instructions for use (ifu) was performed.The ifu states: 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.Investigation conclusion: based on the information available, a 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 the procedure the fiber tip broke off.A new fiber was used to complete the procedure.The procedure was completed with no reported clinical consequences.

• 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: 11787741
• Report Number: 2124215-2021-12178
• Device Sequence Number: 922485
• Product Code: GEX
• UDI-Device Identifier: 00878953000121
• UDI-Public: 00878953000121
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

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: 11/29/2021
• Device Model Number: 0010-6110
• Device Catalogue Number: 0010-6110
• Device Lot Number: 0023006406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1