MIP Minimal Invasive PCNL 27840KARecalls & reported problems
Karl Storz GmbH & Co. KG · Nephroscope for MIP L · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551366660), received between Apr 24, 2024 and Aug 20, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jul 23, 2024Open, Classified
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Z-3225-2024 · Root cause: Process design · FDA record ↗
Most reported problems
Device problems
- Break2
- Improper or Incorrect Procedure or Method1
- Optical Distortion1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026Optical Distortion
The following was reported: "Improper vision while using PCNL scope. The duration of the prolongation was approximately 1 hour. "
Patient problems: Insufficient Information
MAUDE report 50350248 ↗InjuryApr 24, 2024Break; Break
IT WAS REPORTED THAT THE OBJECTIVE LENS COME OUT FROM TIP DURING A PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. ON (B)(6) 2024 WE GOT NEW INFORMATION, THAT DURING PROCEDURE THE LENS FALL OUT INSIDE PATIENT BODY AND CAUSED A PROLONGATION FOR MORE THAN 60 MINUTES. IT IS UNCLEAR IF THE SEPARATED PART COULD BE RETRIEVED. THEREFORE, AS A PRECAUTION, THE CASE IS DEEMED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175981 ↗InjuryApr 24, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE OBJECTIVE LENS COME OUT FROM TIP DURING A PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. ON APRIL 15, 2024 WE GOT NEW INFORMATION, THAT DURING PROCEDURE THE LENS FALL OUT INSIDE PATIENT BODY AND CAUSED A PROLONGATION FOR MORE THAN 60 MINUTES. IT IS UNCLEAR IF THE SEPARATED PART COULD BE RETRIEVED. THEREFORE, AS A PRECAUTION, THE CASE IS DEEMED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175977 ↗
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- Olympus A37025AOLYMPUS Winter & Ibe GmbH · Kit, Nephroscope4 deaths20 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5AOlympus Medical Systems Corp. · Kit, nephroscope9 reports
- n.a. 27290MKarl Storz GmbH & Co. KG · Kit, nephroscope4 reports
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- PANOVIEW PLUS 8965401Richard Wolf GmbH · Kit, nephroscope2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.