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

Model Number	M0068404032
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not used past its expiry date.(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 march 20, 2018 that an accumax 550 laser fiber was opened for use in a procedure performed on (b)(6) 2018.Reportedly, the laser unit used was dornier medialix h20 console.According to the complainant, during preparation and outside the patient, the operator of the device noted that the aiming beam was coming out from the middle of the fiber and not from the tip.The procedure was completed with another accumax 550 laser fiber.There were no patient complications reported as a result of this event.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.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that an accumax 550 laser fiber was opened for use in a procedure performed on (b)(6) 2018.Reportedly, the laser unit used was dornier medialix h20 console.According to the complainant, during preparation and outside the patient, the operator of the device noted that the aiming beam was coming out from the middle of the fiber and not from the tip.The procedure was completed with another accumax 550 laser fiber.There were no patient complications reported as a result of this event.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.
Additional Manufacturer Narrative
One accumax 550 laser fiber was received for evaluation.Visual examination revealed that the exposed glass fiber tip measured approximately 3.5 mm and appeared used.Additional examination under magnification revealed that the pattern on the tip face was consistent with slight degradation.There was no damage along the body of the fiber and to the fiber face within the sma connector.Functional examination revealed that the ¿attach laser fiber¿ message cleared from the console after attachment indicating that the fiber was recognized by the laser.The aiming beam exiting the distal tip was bright, clear and slightly scattered with effective transmission of 90.1%.The condition of the returned device does not confirm that light came out from the middle of the fiber and not from the tip.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) 2018 that an accumax 550 laser fiber was opened for use in a procedure performed on (b)(6) 2018.Reportedly, the laser unit used was dornier medialix h20 console.According to the complainant, during preparation and outside the patient, the operator of the device noted that the aiming beam was coming out from the middle of the fiber and not from the tip.The procedure was completed with another accumax 550 laser fiber.There were no patient complications reported as a result of this event.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.

• 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: 7414237
• Report Number: 3005099803-2018-01091
• Device Sequence Number: 1372809
• Product Code: GEX
• UDI-Device Identifier: 08714729784609
• UDI-Public: 08714729784609
• Combination Product (Y/N): N
• Initial Reporter Country: MT
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2018

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: 07/07/2020
• Device Model Number: M0068404032
• Device Catalogue Number: 840-403
• Device Lot Number: C000004848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 03/20/2018; 06/01/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 04/12/2018; 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1