Model note · PCNL System
KARL STORZ Percutaneous Nephroscope System
The KARL STORZ Percutaneous Nephroscope System is a family of rigid rod lens nephroscopes, sheaths, dilators and hand instruments used in urology theatres to remove kidney stones through a track in the back (PCNL). Its MIP (minimally invasive percutaneous) range shrinks the instruments, for example a 12 Fr nephroscope in a 16.5/17.5 Fr sheath for MIP-M, and relies on controlled irrigation that flushes fragments out without a basket.
The model
Maker, model and type.
- Maker
- KARL STORZ SE & Co. KG (US submitter: KARL STORZ Endoscopy-America, Inc.)
- Model
- Percutaneous Nephroscope System (MIP nephroscopes and HOPKINS PCNL telescopes)
- Device type
- PCNL System
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| System contents | MIP nephroscopes, HOPKINS telescopes for PCNL, operating sheaths, one-step dilators, telescope bougie set, hollow obturator and fascial dilator, forceps, scissors, knives, instrument port, laser hand instrument, suction tube, adaptors | Source |
| Optics | Rigid rod lens telescopes | Source |
| MIP-M set | 12 Fr nephroscope, 16.5/17.5 Fr operating nephrostomy (Amplatz) sheath, single-step dilator and grasping forceps | Source |
| MIP-M stone size | Suited to stones 12 to 24 mm in any calyx or the renal pelvis | Source |
| Compatible lithotripsy (MIP-M) | Lithotripsy devices down to 5 Fr, ballistic probes up to 2 mm, laser fibres 200 to 600 micrometres | Source |
| Fascial dilator sizes | 9 to 30 Fr in 3 Fr steps | Source |
| Indications | Percutaneous kidney stone removal in adults, and in children over 1 month for the paediatric configuration | Source |
| Regulatory class | FDA Class II nephroscope kit, 21 CFR 876.1500, product code FGA | Source |
| Standards tested | ISO 8600 endoscope series and IEC 60601-2-18 thermal safety | Source |
Recalls
Known FDA recalls.
- Z-3224-20242024-07-23
Nephroscope for MIP M (REF 27830KA): IFU contained reprocessing methods not reviewed or approved by the FDA.
FDA record - Z-3225-20242024-07-23
Nephroscope for MIP L (REF 27840KA): same reprocessing IFU issue.
FDA record
Safety
Safety warnings from the record.
- Some KARL STORZ IFUs, including those for MIP M and MIP L nephroscopes, listed reprocessing methods not reviewed by the FDA. Follow the corrected instructions. Source
- Irrigation is run under controlled pressure, and the sheath design helps limit fluid overload; monitor irrigation pressure and volume throughout. Source
- Using MIP-M for stones larger than its suggested range can lengthen surgery and raise complication risk. Source
- Stone fragmentation equipment must be on hand and confirmed compatible with the MIP-M system before the case starts. Source
Sources
Where this note comes from.
- FDA 510(k) K232370 summary, KARL STORZ Percutaneous Nephroscope System
- NICE MIB138, MIP-M for removing kidney stones, The technology
- openFDA MAUDE problem counts, KARL STORZ nephroscopes
- openFDA recalls, KARL STORZ nephroscopes
Not covered: This is a passive optical instrument set with no error codes; no public KARL STORZ instructions for use or reprocessing manual were reviewed, so exact scope lengths, channel sizes per model and the repair inspection procedure are not included, and the first checks on lens and shaft inspection are general practice linked to MAUDE trends rather than a Storz procedure.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
PCNL System