HOPKINS 26105FARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04048551093610), received between Feb 13, 2026 and Aug 25, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Optical Distortion” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Optical Problem

  New information was received August 10, 2026: The affected material number is 26105FA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439101 ↗
• MalfunctionJul 13, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25801811 ↗
• MalfunctionJul 9, 2026Optical Distortion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25769183 ↗
• InjuryJun 2, 2026Optical Distortion

  THE FOLLOWING WAS REPORTED: THE PATIENT ENTERED THE OPERATING ROOM AT 08:40 ON (B)(6) 2026, AND ROUTINE PREOPERATIVE PREPARATION WAS PERFORMED. THE LITHOTOMY POSITION WAS ASSUMED AT 09:00, FOLLOWED BY ROUTINE DISINFECTION AND DRAPING. TRANSURETHRAL VAPORIZATION RESECTION OF THE PROSTATE WAS FORMALLY INITIATED AT 09:23. THE PRIMARY SURGICAL OBJECTIVE WAS TO RESECT HYPERPLASTIC PROSTATIC TISSUE TO RELIEVE THE PATIENT'S URINARY OBSTRUCTION AND RELATED SYMPTOMS AND IMPROVE PROGNOSIS. DURING THE PROCEDURE, WHILE USING THE HIGH-FREQUENCY ELECTROSURGICAL SYSTEM TO RESECT HYPERPLASTIC PROSTATIC TISSUE, THE RESECTOSCOPE DISPLAYED A BLURRED IMAGE WITH GHOSTING SHADOWS, SEVERELY OBSTRUCTING THE SURGICAL FIELD OF VIEW, WHICH LED TO A SURGICAL ERROR CAUSING PROSTATIC BLEEDING IN THE PATIENT, WITH AN ESTIMATED BLOOD LOSS OF APPROXIMATELY 200 ML. THE SURGEON IMMEDIATELY USED THE RESECTOSCOPE LOOP FOR ELECTROCOAGULATION HEMOSTASIS, WHICH WAS COMPLETED AT 10:55. THE PATIENT'S VITAL SIGNS WERE MONITORED TO ENSURE STABILITY. FOLLOWING THE MALFUNCTION, A BACKUP RESECTOSCOPE WAS IMMEDIATELY REPLACED. THE SURGERY CONCLUDED UNEVENTFULLY AT 11:30, AND THE PATIENT WAS SAFELY RETURNED TO THE WARD. DUE TO TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25366159 ↗
• MalfunctionApr 2, 2026Optical Distortion

  THE FOLLOWING WAS REPORTED: "OPTICAL SYSTEM FOGGY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24769437 ↗
• MalfunctionMar 26, 2026Optical Distortion; Device Contaminated at the User Facility

  THE FOLLOWING WAS REPORTED: "OPTICAL SYSTEM: BLURRED IMAGE. FOGGY." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24708184 ↗
• MalfunctionMar 26, 2026Chemical Problem; Optical Distortion

  THE FOLLOWING WAS REPORTED: "OPTICAL SYSTEM: FOGGY." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24707781 ↗
• MalfunctionMar 4, 2026Poor Quality Image; Chemical Problem; Failure to Clean Adequately

  IT WAS REPORTED THAT "OPTICAL SYSTEM: BLURRED IMAGE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510352 ↗
• MalfunctionFeb 13, 2026Optical Problem

  IT WAS REPORTED THAT DURING THE USE OF THE HYSTEROSCOPIC RESECTOSCOPE, THE MEDICAL STAFF FOUND BLURRY AND ABNORMAL IMAGES ON THE LENS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337828 ↗