InjuryOCZ
BLADDER URINARY STORZ MODEL 27074B OPTICAL STONE CRUSHING FORCEPS
Received Nov 4, 2021 · Event occurred Oct 11, 2021
Report MW5105156 · MDR key 12771129
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Karl Storz Endoscopy-america, Inc.Product problems
- Entrapment of Device
- Material Fragmentation
Patient
1 YR · Prefer Not To Disclose
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
TIP OF STORZ MODEL 27074B OPTICAL STONE CRUSHING FORCEPS WAS NOTED TO HAVE TIP FRAGMENT BREAK WHERE ACTUATOR ROD CONNECTS TO THE MOVEABLE JAW RESULTING IN FRAGMENTS OF DEVICE THAT REQUIRED MANUAL REMOVAL FROM THE PATIENT'S BLADDER. FDA SAFETY REPORT ID # (B)(4).