MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068404020
Medical Device Problem Codes	Break (1069); Melted (1385); Misfire (2532)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device component code relates to device problem code for the evaluation findings of fiber broke.Device component code relates to device problem code for the evaluation findings of fiber misfired.Device component codes relates to device problem code 1385 for the evaluation findings of fiber connector boot melted.Mfg site name (b)(4).One accumax 365 laser fiber was received for evaluation.Visual examination revealed that the exposed glass fiber tip measured approximately 3.5 mm and appeared unused.Additional examination under magnification confirmed that the tip was unused.The fiber was broken underneath the black strain relief boot.The black strain relief under the boot was melted at the break indicating that the fiber broke while in use.The condition of the returned device would cause it to have no energy thereby confirming the event.The noted damages indicate difficulty was experienced during the procedure and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that an accumax 365 laser fiber was used during a ureteroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the laser fiber failed to work.Smoke was noted coming from the sma connector.The procedure was completed with another accumax 365 laser fiber.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available; a supplement report will be submitted.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the fiber was broken underneath the black strain relief boot.

• Brand Name: ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7118061
• Report Number: 3005099803-2017-03655
• Device Sequence Number: 1156149
• Product Code: GEX
• UDI-Device Identifier: 08714729784593
• UDI-Public: 08714729784593
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K082928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2017

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: 08/17/2020
• Device Model Number: M0068404020
• Device Catalogue Number: 840-402
• Device Lot Number: 0000004980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2017
• Initial Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1