MAUDE Adverse Event Report: OLYMPUS EUROPA SE & CO.KG/GYRUS ACMI, INC. OLYMPUS SOLTIVE SURGICAL LASER; POWERED LASER SURGICAL INSTRUMENT

Model Number	TFL-CPLU
Health Effect - Clinical Codes	Laceration(s) (1946); Unspecified Kidney or Urinary Problem (4503)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent surgical laser treatment of left ureteral stones on (b)(6) 2022.The provider used the olympus soltive thulium laser with 0.4 -1j energy, frequency of 16-40jz, power of 12.8-40w over 9mins 52 secs for total energy of 32.57kj.The patient underwent a second laser lithotripsy of left ureteral stone on (b)(6) 2022 with the same laser, 1j energy with 20hz frequency, 20w power over 39 minutes for a total of 59.26kj was used.The patient returned a third time for similar problem, and it was determined that he had a segment of avascularized nonviable ureter that required corrective surgery.Patient underwent the corrective surgery and has done well since.

• Brand Name: OLYMPUS SOLTIVE SURGICAL LASER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): OLYMPUS EUROPA SE & CO.KG/GYRUS ACMI, INC.
• MDR Report Key: 15977674
• Report Number: MW5113770
• Device Sequence Number: 7224199
• Product Code: GEX
• UDI-Device Identifier: 00821925044586
• UDI-Public: (01)00821925044586
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/09/2022

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 Model Number: TFL-CPLU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White