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

Model Number	M0068404012
Medical Device Problem Codes	Break (1069); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(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) 2019 that an accumax 200 laser fiber was used in a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2019.Reportedly, the laser unit used was a dornier laser console.According the complainant, during procedure, while firing the laser fiber, the fiber broke and a hole was created in the navigator sheath.The procedure was completed with another accumax 200 laser fiber.There were no serious injury nor adverse patient effects reported as a result of this event.

• Brand Name: ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8540665
• Report Number: 3005099803-2019-02088
• Device Sequence Number: 13889387
• Product Code: GEX
• UDI-Device Identifier: 08714729784623
• UDI-Public: 08714729784623
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093691
• 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
• Report Date (Section B): 04/23/2019

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: 02/09/2021
• Device Model Number: M0068404012
• Device Catalogue Number: 840-401
• Device Lot Number: 0000005634
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1