Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medsun Reports
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

Back to search results
Type of Device:
Powered laser surgical instrument
Device Brand Name:
Device Manufacturer's Name:
GYRUS ACMI, INC.
Date of this Report:
(mm/dd/yyyy)
07/05/2024
Describe the Event
or Problem:
Elderly female with history of right renal stone. Procedure: right ureteroscopy. Laser fiber snapped while in the patient. No known harm to patient. Piece inside of patient was able to be removed.
======================
Manufacturer response for Superpulsed laser fiber, Soltive (per site reporter)
======================
Will obtain.
the device(s) may have
caused or contributed to:
Potential for patient harm
New Search
-
-