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); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the physician found the fiber was not emitting energy after 2 joules and 11 seconds of use.A break was observed on the fiber body and low level energy was observed to be emitted from the location of the break.The fiber was replaced and a second fiber was used to complete the procedure without any consequences to the patient.
Event or Problem Description
It was reported that during a procedure, the physician found the fiber was not emitting energy after 2 joules and 11 seconds of use.A break was observed on the fiber body and low level energy was observed to be emitted from the location of the break.The fiber was replaced and a second fiber was used to complete the procedure without any consequences to the patient.
Additional Manufacturer Narrative
Investigation summary: with the available information boston scientific concluded that the reported fiber break was confirmed as analysis found a break in the fiber body.Analysis also found the metal tip was bent and the glass cap/tip was broken.It is probable that the observed condition of the fiber occurred due to excessive manipulation of the fiber during the procedure.The interaction between the user and the device caused or contributed to the error.Device history record (dhr) review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the fiber was returned and upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Analysis of the fiber found a break in the fiber body.The metal tip was bent, and the glass cap/tip was broken.Labeling review: the device instructions for use (ifu) was reviewed.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.

• 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: 11952343
• Report Number: 2124215-2021-15641
• Device Sequence Number: 1058433
• 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
• 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): 07/20/2021

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: 12/13/2021
• Device Model Number: 0010-6110
• Device Catalogue Number: 0010-6110
• Device Lot Number: 0023079828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR