MalfunctionFBO
INNER SHEATH
Received Mar 5, 2021 · Event occurred Mar 2, 2021
Report MW5099830 · MDR key 11435257
Device
Generic name
Cystourethroscope
Manufacturer
Karl Storz Endovision, Inc.Catalog number
27040 XA
Lot number
WP09
Product problems
- Break
- Device Dislodged or Dislocated
Patient
77 YR
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
DURING A TRANSURETHRAL RESECTION OF PROSTATE (TURP), THE TIP OF THE INNER SHEATH BECAME DISLODGED AND BROKE INTRA-OPERATIVELY AND WAS EMBEDDED IN THE PATIENT'S TISSUE WITHIN THE OPERATIVE SITE. ALL FRAGMENTS WERE REMOVED PER THE OPERATING MD INTRA-OPERATIVELY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INJURY. FDA SAFETY REPORT ID # (B)(4).