S-PILOT UP501Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04048551354155), received between Jul 11, 2023 and Apr 24, 2026 — classified as 2 deaths, 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Mechanical Jam

  IT WAS REPORTED THAT THE VALVE DID NOT OPEN DURING THE PROCEDURE. CONSEQUENTLY, THE SUCTION DID NOT WORK, AND THEY HAD TO CONVERT TO BIPOLAR IN ORDER TO REMOVE THE PROSTATE ADENOMA, WHICH PROLONGED THE PROCEDURE BY MORE THAN TWO HOURS. SINCE THE PROCEDURE WAS PROLONGED BY TWO HOURS, THE CASE IS DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988226 ↗
• InjuryAug 6, 2025Mechanical Problem; Improper Flow or Infusion; Mechanical Problem

  THE FOLLOWING WAS REPORTED: AT THE START OF SURGERY, THE PINCH VALVE OF THE PRODUCT REMAINED OPEN, AND ATTEMPTS TO TURN THE POWER ON AND OFF DID NOT IMPROVE THE SITUATION.

  Patient problems: Insufficient Information

  MAUDE report 22730364 ↗
• InjuryAug 6, 2025Mechanical Problem; Mechanical Problem

  THE FOLLOWING WAS REPORTED: AT THE START OF SURGERY, THE PINCH VALVE OF THE PRODUCT REMAINED OPEN, AND ATTEMPTS TO TURN THE POWER ON AND OFF DID NOT IMPROVE THE SITUATION.

  Patient problems: Insufficient Information

  MAUDE report 22730201 ↗
• DeathMar 24, 2025Power Problem; Unexpected Shutdown; Power Problem; Unexpected Shutdown

  IT WAS REPORTED THAT "THE INITIAL CHECKS WERE DONE, THE S-PILOT WAS WORKING, INTRA-OPERATIVELY POWER COULD NOT BE ESTABLISHED. A PROLONGED MORCELLATION TIME WAS INDICATED. THE WHOLE PROCEDURE WAS PROLONGED MORE THAN 60 MINUTES. AS CONSEQUENCE, FURTHER INTERVENTIONS WERE REQUIRED (CT SCAN, X-RAY AND ITU ADMISSION) AND THEREFORE ADDITIONAL HOSPITALIZATION NECESSARY. IN ADDITION, ON (B)(6) 2025 THE INFORMATION WAS RECEIVED THAT THE PATIENT HAS PASSED AWAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pulmonary Edema

  MAUDE report 21681389 ↗
• DeathMar 24, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT, THE INITIAL CHECKS WERE DONE, THE S-PILOT WAS WORKING, INTRA-OPERATIVELY POWER COULD NOT BE ESTABLISHED. A PROLONGED MORCELLATION TIME WAS INDICATED. THE WHOLE PROCEDURE WAS PROLONGED MORE THAN 60 MINUTES. AS CONSEQUENCE, FURTHER INTERVENTIONS WERE REQUIRED (CT SCAN, X-RAY AND ITU ADMISSION) AND THEREFORE ADDITIONAL HOSPITALIZATION NECESSARY. IN ADDITION, ON 2025-03-19, THE INFORMATION WAS RECEIVED THAT THE PATIENT HAS PASSED AWAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21679543 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE UP501 DID NOT WORK DURING THE PROCEDURE. THE PROCEDURE HAD TO BE ABORTED AND WAS CONTINUED AFTER TWO DAYS.

  Patient problems: Insufficient Information

  MAUDE report 17298876 ↗
• InjuryJul 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE UP501 DID NOT WORK DURING THE PROCEDURE. THE PROCEDURE HAD TO BE ABORTED AND WAS CONTINUED AFTER TWO DAYS.

  Patient problems: Insufficient Information

  MAUDE report 17298872 ↗