Trokamed WA2PS20LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04251303810919), received between May 8, 2024 and Jun 14, 2024 — classified as 2 deaths.

The most frequently reported specific device problem is “Inability to Irrigate” (1 report).

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.

Recalls naming this device

1. Nov 27, 2024Open, Classified

   If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

   Z-0714-2025 · Root cause: Labeling False and Misleading · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJun 14, 2024Restricted Flow rate; Inability to Irrigate; Restricted Flow rate; Inability to Irrigate

  ON (B)(6) 2024: THE PATIENT WAS TREATED IN HOSPITAL WITH THE OLYMPUS MINI-PCNL TRAY MINI NEPHROSCOPE DUE TO THE FOLLOWING DIAGNOSIS: 4-CM OBSTRUCTIVE LEFT PELVIC STAGHORN CALCULUS WITH CHRONIC HYDRONEPHROSIS AND RENAL CORTICAL THINNING, MULTIPLE NONOBSTRUCTIVE LEFT RENAL CALYCEAL CALCULI, MARGINAL KIDNEY FUNCTION AT 20%. DURING THE PROCEDURE, THE PHYSICIAN RECOGNISED THAT THERE WAS NOT ENOUGH OUTFLOW FROM THE WORKING SHEATH TOGETHER WITH POOR VISUALIZATION, RESULTING IN INCREASED INTRARENAL PRESSURE. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO SWITCH IRRIGATION PORT AND TESTED FOR POSSIBLE CONTINUOUS FLOW, BUT THIS WAS UNSUCCESSFUL. AS A FINAL SOLUTION DURING SURGERY, THE PHYSICIAN HAD TO REMOVE THE NEPHROSCOPE INTERMITTENTLY TO LET THE IRRIGATION DRAIN OUT AND PRESSURE IRIGATION WAS USED. THE SURGERY CONTINUED AND THE STONE WAS BROKEN COMPLETELY WITH A LARGE BORE LASER. THE PHYSICIAN LATER REALIZED THAT HE WAS NO LONGER GETTING FLOW OUT, EVEN WHEN HE REMOVED THE NEPHROSCOPE. HE DECIDED TO PLACE STENTS, STOP THE PROCEDURE, AND PERFORM THE REST OF THE PROCEDURE AT ANOTHER TIME. THE PATIENT DEVELOPED ASCITES AND ABOUT 1 LITER WAS DRAINED A RUPTURE OF THE LOWER KIDNEY AND OOZING WAS VISIBL

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Respiratory Failure; Shock

  MAUDE report 19536011 ↗
• DeathMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE, THERE WAS NO FLOW OUT OF THE OUTER SHEATH RESULTING IN INCREASED INTRARENAL PRESSURE CAUSING COMPLICATIONS. WHEN AN OLYMPUS REPRESENTATIVE WAS ONSITE AT THE CUSTOMER, THEY WERE INFORMED THAT AFTER THE PCNL PROCEDURE THE PATIENT HAD ADDITIONAL SURGERIES AND ENDED UP PASSING AWAY. THE PATIENT WAS INITIALLY DIAGNOSED WITH A 4-CENTIMETER OBSTRUCTIVE LEFT PELVIC STAGHORN CALCULUS WITH CHRONIC HYDRONEPHROSIS AND RENAL CORTICAL THINNING WITH MULTIPLE NON-OBSTRUCTIVE LEFT RENAL CALYCEAL CALCULI. THE PATIENT HAD MARGINAL KIDNEY FUNCTION AT 20%. THE PATIENT DID NOT WANT TO LOSE HER KIDNEY. THE SURGEON DISCUSSED OPTIONS WITH THE PATIENT AND INFORMED HER THAT SHE WOULD LIKELY LOSE THE KIDNEY IN THE FUTURE, BUT THEY DECIDED "TO GIVE THIS PROCEDURE A TRY". ON (B)(6) 2024 THE PATIENT UNDERWENT A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE USING AN OLYMPUS MINI-PCNL TRAY WITH MINI NEPHROSCOPE. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WAS NOT ENOUGH OUTFLOW FROM THE WORKING SHEATH AND THERE WAS POOR VISUALIZATION. SEVERAL ATTEMPTS WERE MADE TO SWITCH THE IRRIGATION PORT AND TEST FOR POSSIBLE CONTINUOUS FLOW, BUT THEY

  Patient problems: Aneurysm; Ascites; Cardiac Arrest; Disseminated Intravascular Coagulation (DIC); Hemorrhage/Blood Loss/Bleeding; Hypoxia; Increased Intra-Peritoneal Volume (IIPV); Ischemia; Necrosis; Respiratory Failure; Rupture; Septic Shock; Thrombosis/Thrombus; Unspecified Kidney or Urinary Problem; Vascular Dissection

  MAUDE report 19273992 ↗