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

Model Number	M0068404020
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2017
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) 2017 that an accumax 365 laser fiber was used during a ureteral soft lens lithotripsy procedure in the ureter performed on (b)(6) 2017.Reportedly, the laser unit used was a lumenis 30w.According to the complainant, during preparation and outside the patient, laser energy was seen exiting outside of its intended tip location.The procedure was completed with a different device.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 stable.
Additional Manufacturer Narrative
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.There was no damage along the body of the fiber and to the fiber face within the sma connector.There was no light was leaking from the body of the fiber.The ¿attach laser fiber¿ message cleared from the console after attachment indicating that the fiber was recognized by the laser unit.The aiming beam exiting the distal tip was bright, clear and round with effective transmission measures of 99.1%.Therefore, based on all gathered information, the reported issue was unable to be confirmed.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 ureteral soft lens lithotripsy procedure in the ureter performed on (b)(6) 2017.Reportedly, the laser unit used was a lumenis 30w.According to the complainant, during preparation and outside the patient, laser energy was seen exiting outside of its intended tip location.The procedure was completed with a different device.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 stable.

• 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: 6609207
• Report Number: 3005099803-2017-01585
• Device Sequence Number: 10843899
• Product Code: GEX
• UDI-Device Identifier: 08714729784593
• UDI-Public: (01)08714729784593(17)20191115(10)C000003866
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K082928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2017

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: 11/15/2019
• Device Model Number: M0068404020
• Device Catalogue Number: 840-402
• Device Lot Number: C000003866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1