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

Model Number	M0068404030
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 550 laser fiber was used in a stone rubble procedure performed on (b)(6) 2018.According to the complainant, during preparation, the tip of the laser fiber was noted to have black spots.The procedure was completed with another accumax 550 laser fiber.There were no serious injury nor adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
Problem code 2976 captures the reportable event of fiber tip/face material deformation.Investigation results: one flexiva 200 tractip laser fiber was returned intact in one piece.The fiber measured approximately 278.9 cm from the top of the connector which includes the entire distal tip.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.Functional analysis revealed that when the fiber was connected to the lumenis laser console, the attach fiber message disappeared indicating that the fiber was recognized by the console.The aiming beam exiting the distal tip is bright, clear, and round.The reported complaint was not confirmed.Therefore, a review and analysis of all available information indicated that the root cause is no problem detected.A complaint with a cause of no problem detected indicates that the device complaint or problem cannot be confirmed.A review of the device history record (dhr) was performed; no anomalies were noted.
Event or Problem Description
It was reported to boston scientific corporation on october 29, 2018 that an accumax 550 laser fiber was used in a stone rubble procedure performed on (b)(6) 2018.According to the complainant, during preparation, the tip of the laser fiber was noted to have black spots.The procedure was completed with another accumax 550 laser fiber.There were no serious injury nor adverse patient effects reported as a result of this event.

• Brand Name: ACCUMAX
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8096359
• Report Number: 3005099803-2018-61556
• Device Sequence Number: 2792315
• Product Code: GEX
• UDI-Device Identifier: 08714729784609
• UDI-Public: 08714729784609
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/30/2019

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: M0068404030
• Device Catalogue Number: 840-403
• Device Lot Number: C000004847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1