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

Model Number	M0068404012
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that an accumax 200 laser fiber was used during a cystoscopy, ureteroscopy, stone removal and stent placement procedure in the bladder and ureter performed on (b)(6) 2018.Reportedly, the laser unit used was dornier 20 watt console.According to the complainant, during the procedure and inside the patient, the physician noted that the laser fiber was not emitting enough laser energy to break the stone even after increasing the laser settings to 1 joule.The nurse remove the laser fiber and noted that the fiber connector was hot to touch.Reportedly, the nurse was not burned.The procedure was completed with another accumax 200 laser fiber.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that an accumax 200 laser fiber was used during a cystoscopy, ureteroscopy, stone removal and stent placement procedure in the bladder and ureter performed on (b)(6) 2018.Reportedly, the laser unit used was dornier 20 watt console.According to the complainant, during the procedure and inside the patient, the physician noted that the laser fiber was not emitting enough laser energy to break the stone even after increasing the laser settings to 1 joule.The nurse remove the laser fiber and noted that the fiber connector was hot to touch.Reportedly, the nurse was not burned.The procedure was completed with another accumax 200 laser fiber.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Investigation results: one accumax 200 laser fiber was received for evaluation.Visual analysis 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 investigator was unable to examine  the fiber face within the sma connector because light was unable to travel to the fiber face to illuminate it, this indicated that the fiber was broken within the connector.The condition of the returned device would cause the connector to overheat and result in insufficient energy transmission during ablation 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.

• 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: 7694593
• Report Number: 3005099803-2018-02215
• Device Sequence Number: 16424262
• Product Code: GEX
• UDI-Device Identifier: 08714729784623
• UDI-Public: 08714729784623
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K093691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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 Expiration Date: 03/06/2021
• Device Model Number: M0068404012
• Device Catalogue Number: 840-401
• Device Lot Number: 0000005739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1