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

Model Number	M0068404020
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned accumax laser fiber was analyzed, and a visual evaluation noted that the laser fiber was received for analysis in two pieces.Piece one of the fiber measured 200 cm and included the sma connector, piece two measured 77 cm.A functional evaluation noted that the light from the sma connector was bright and round, indicating no fracture within the fiber connector.Examination under magnification identified the tip was chipped/damaged.No other issues with the device were noted.The reported event was confirmed.Analysis of the returned device observed the fiber body fractured along its length, 200 cm from the end of the sma connector.Additionally, the exposed glass tip was observed chipped/damaged.The fiber packaging was not returned to identify any damages or defects.However, based on all available information, the condition of the fiber and results of the product record review, the fiber was likely damaged during transport or storage of the device.Therefore, the most probable cause assigned is cause traced to transport/storage.
Event or Problem Description
It was reported to boston scientific corporation that an accumax laser fiber was opened prior to a procedure performed on (b)(6) 2021.Upon opening the package, the physician assistant (pa) noticed that the fiber was broken in the middle of the fiber body.The procedure was completed with another accumax laser fiber.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of tip chipped/damaged.

• Brand Name: ACCUMAX
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12698894
• Report Number: 3005099803-2021-05382
• Device Sequence Number: 19173281
• Product Code: GEX
• UDI-Device Identifier: 08714729784593
• UDI-Public: 08714729784593
• Combination Product (Y/N): N
• PMA/510(K) Number: K082928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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: 04/01/2024
• Device Model Number: M0068404020
• Device Catalogue Number: 840-402
• Device Lot Number: 0000010867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1