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

Model Number	M0068404040
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
When we began the turp, the doctor found a few huge bladder stones that he used the holmium laser for to break up the stones.It took several hours to break up the stones.We went through five laser fibers; four of the fibers did not last very long and had to be replaced within an unusually short timeframe.The tip of the laser fiber was used up much faster than normal according to the surgeon.All four laser fibers that were of short duration were saved, with all the packages.

• Brand Name: ACCUMAX
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7909367
• Report Number: 7909367
• Device Sequence Number: 2052396
• Product Code: GEX
• UDI-Device Identifier: 08714729784616
• UDI-Public: (01)08714729784616
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/21/2018
• Report Date (Section F): 09/21/2018

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 Model Number: M0068404040
• Device Catalogue Number: M0068404040
• Device Lot Number: 0000005308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2018
• Patient Sequence Number: 1
• Patient Weight: 75
• Date Report Sent to FDA: 09/21/2018