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

Model Number	M0068404010
Medical Device Problem Codes	Break (1069); Misfire (2532)
Health Effect - Clinical Codes	Burn(s) (1757); No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received but an evaluation has not yet been performed; therefore, a failure analysis is not available.If there is any further relevant information received, a supplemental medwatch report will be filed.
Event or Problem Description
It was reported to boston scientific corporation on november 26, 2018 that an accumax 200 laser fiber was opened for use for a urs procedure performed on (b)(6) 2018.According to the complainant, the laser fiber broke causing a burn to the user's third finger on their right hand and burnt a hole in the drape.The burn was treated with cold water.The procedure was completed with another accumax 200 laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code 1069 captures the reportable event of fiber broke.Problem code 2532 captures the reportable event of fiber misfired.Problem code 1757 captures the reportable event of user burn.The device has been received but an evaluation has not yet been performed; therefore, a failure analysis is not available.If there is any further relevant information received, a supplemental medwatch report will be filed.Additional information received on 08jan2019.Block b5 and e1 (initial reporter title, first name, last name) have been updated.
Event or Problem Description
It was reported to boston scientific corporation on november 26, 2018 that an accumax 200 laser fiber was opened for use for a urs procedure performed on (b)(6) 2018.According to the complainant, the laser fiber broke causing a burn to the user's third finger on their right hand and burnt a hole in the drape.The burn was treated with cold water.The procedure was completed with another accumax 200 laser fiber.There were no patient complications reported as a result of this event.**additional information received on 08jan2018: the procedure performed in the ureter/kidney using a lumenis p20 console with laser settings of 0.6 hertz and 1.2 joules.The event occurred during the procedure.
Additional Manufacturer Narrative
H6: problem code 1069 captures the reportable event of fiber broke.Problem code 2532 captures the reportable event of fiber misfired.Problem code 1757 captures the reportable event of user burn.The fiber was returned broken into two pieces.The first piece measured approximately 154.6 cm from the top of the connector to the break.The second piece measured approximately 161.2 cm from the break to the tip.The exposed glass portion of the distal tip measures approximately 0.2 cm.The pattern on the tip face is consistent with a tip detachment, likely as a result of handling during the procedure.Visual inspection of the returned fiber noted burn marks on the fiber jacketing, likely a result of the fiber break occurring during use, resulting in a misfire.The condition of the returned device confirmed that the fiber was broken.Review and analysis of all available information indicated that the root cause is manufacturing deficiency.A complaint with a cause of manufacturing deficiency indicates that the problems were traced to the manufacturing process.An investigation was completed to address this issue which identified the most probable root cause of the fiber break as handling during the manufacturing process caused by the supplier manufacturer.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.A search of the complaint database confirmed that no other complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation on november 26, 2018 that an accumax 200 laser fiber was opened for use for a urs procedure performed on (b)(6) 2018.According to the complainant, the laser fiber broke causing a burn to the user's third finger on their right hand and burnt a hole in the drape.The burn was treated with cold water.The procedure was completed with another accumax 200 laser fiber.There were no patient complications reported as a result of this event.Additional information received on 08jan2018: the procedure performed in the ureter/kidney using a lumenis p20 console with laser settings of 0.6 hertz and 1.2 joules.The event occurred during the procedure.

• Brand Name: ACCUMAX
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 8186364
• Report Number: 3005099803-2018-62106
• Device Sequence Number: 2025069
• Product Code: GEX
• UDI-Device Identifier: 08714729784586
• UDI-Public: 08714729784586
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 02/13/2019

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: 10/04/2021
• Device Model Number: M0068404010
• Device Catalogue Number: 840-401
• Device Lot Number: 0000006692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 01/08/2019; 02/05/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/28/2019; 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1