MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M0067913600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.Report source: majdalany se, levin ba, ghani kr.The efficiency of moses technology holmium laser for treating renal stones during flexible ureteroscopy: relationship between stone volume, time, and energy.J endourol.2021 dec;35(s3):s14-s21.Doi: 10.1089/end.2021.0592.Pmid: 34910609.(b)(4).
Event or Problem Description
It was reported to boston scientific via an article, the efficiency of moses technology holmium laser for treating renal stones during flexible ureteroscopy: relationship between stone volume, time, and energy.It was examined the relationship of stone volume and density to lithotripsy, lasing times, and energy used to treat a single renal stone.Out of the twenty-nine patients involved in the study, some patients had postoperative complications.Three (10.3%) had a clavien-dindo grade 1 complication.One patient made an office phone call for stent-related pain treated with analgesics.Two patients had an ed visit, one for urinary retention treated with a foley catheter and removed in the office.The second patient had flank pain, resolved with early removal of the stent.No patients required unplanned surgical intervention.

• Brand Name: LITHOVUE
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15574045
• Report Number: 3005099803-2022-05772
• Device Sequence Number: 14199198
• Product Code: FGB
• UDI-Device Identifier: 08714729874812
• UDI-Public: 08714729874812
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K153049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M0067913600
• Device Catalogue Number: 791-360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown