HOPKINS 26105BARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04048551093597), received between Feb 6, 2020 and Jul 15, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25830820 ↗
• MalfunctionJun 23, 2026Poor Quality Image

  IT WAS REPORTED THAT "THE HYSTEROSCOPE IMAGE WAS BLURRY AFTER BEING CONNECTED TO THE SYSTEM AND COULD NOT MEET SURGICAL IMAGING REQUIREMENTS.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25600850 ↗
• MalfunctionMar 19, 2026Optical Distortion

  THE FOLLOWING WAS REPORTED: FOGGY IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644465 ↗
• MalfunctionFeb 5, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THE ROD LENS OF FOUR HYSTEROSCOPES HAS ALREADY BROKEN 4 TIMES. UNFORTUNATELY, THERE IS NO LONGER SUFFICIENT VISIBILITY TO OPERATE. NO DEATH OR UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-00131 9610617-2025-00133 9610617-2025-00134.

  Patient problems: Insufficient Information

  MAUDE report 21318177 ↗
• MalfunctionFeb 5, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THE ROD LENS OF FOUR HYSTEROSCOPES HAS ALREADY BROKEN 4 TIMES. UNFORTUNATELY, THERE IS NO LONGER SUFFICIENT VISIBILITY TO OPERATE. NO DEATH OR UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 21318174 ↗
• MalfunctionFeb 5, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THE ROD LENS OF FOUR HYSTEROSCOPES HAS ALREADY BROKEN 4 TIMES. UNFORTUNATELY, THERE IS NO LONGER SUFFICIENT VISIBILITY TO OPERATE. NO DEATH OR UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-00131. 9610617-2025-00132. 9610617-2025-00134.

  Patient problems: Insufficient Information

  MAUDE report 21318172 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THE ROD LENS OF FOUR HYSTEROSCOPES HAS ALREADY BROKEN 4 TIMES. UNFORTUNATELY, THERE IS NO LONGER SUFFICIENT VISIBILITY TO OPERATE. NO DEATH OR UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-00132, 9610617-2025-00133 AND 9610617-2025-00134.

  Patient problems: Insufficient Information

  MAUDE report 21318169 ↗
• MalfunctionSep 6, 2023Poor Quality Image; Optical Distortion; Poor Quality Image; Optical Distortion

  IT WAS REPORTED THAT THE PATIENT HAD CONSENTED TO HYSTEROSCOPY AND TCRF. THE SCOPE HAD BEEN CHECKED BEFORE THE PROCEDURE AND THE VISION WAS CLEAR EVEN DURING HYSTEROSCOPY. AFTER CONNECTING TO BIPOLAR RESECTOSCOPE THE SURGEON REPORTED THAT THE VISION BECAME FOGGY AND BLURRY WHILE IN THE CAVITY. WE CHANGED TO ANOTHER SCOPE WHICH WAS CLEAR AND THE SURGEON WAS HAPPY WITH IT. WHEN HE INSERTED IT IN THE PATIENT'S UTERINE CAVITY THE SURGEON REPORTED THE SECOND SCOPE WAS ALSO FOGGY AND BLURRY. AS BOTH SCOPES WERE NOT CLEAR THE SURGEON DECIDED IT WAS NOT SAFE TO PROCEED AND ABANDONED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691480 ↗
• MalfunctionSep 6, 2023Poor Quality Image; Optical Distortion; Poor Quality Image; Optical Distortion

  IT WAS REPORTED THAT THE PATIENT HAD CONSENTED TO HYSTEROSCOPY AND TCRF. THE SCOPE HAD BEEN CHECKED BEFORE THE PROCEDURE AND THE VISION WAS CLEAR EVEN DURING HYSTEROSCOPY. AFTER CONNECTING TO BIPOLAR RESECTOSCOPE THE SURGEON REPORTED THAT THE VISION BECAME FOGGY AND BLURRY WHILE IN THE CAVITY. WE CHANGED TO ANOTHER SCOPE WHICH WAS CLEAR AND THE SURGEON WAS HAPPY WITH IT. WHEN HE INSERTED IT IN THE PATIENT'S UTERINE CAVITY THE SURGEON REPORTED THE SECOND SCOPE WAS ALSO FOGGY AND BLURRY. AS BOTH SCOPES WERE NOT CLEAR THE SURGEON DECIDED IT WAS NOT SAFE TO PROCEED AND ABANDONED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691479 ↗
• MalfunctionSep 5, 2023Crack; Crack

  IT WAS REPORTED THAT THE DURING A HOLEP RESECTION THE REUSABLE BIPOLAR LOOP SEPARATED IN THE PATIENT. ACCORDING TO THE INFORMATION RECEIVED, NO HARM TO PATIENT, USER OR THIRD OCCURRED. THE CASE COULD BE COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686918 ↗
• InjuryFeb 6, 2020Use of Device Problem; Use of Device Problem

  AS PER A VIGILANCE REPORT RECEIVED FROM THE FACTORY IN (B)(4), A PATIENT RECEIVED A BURN ON THE INNER ASPECT OF THE LEFT THIGH THOUGHT TO HAVE OCCURRED BY THE END OF THE HYSTEROSCOPE COMING INTO CONTACT WITH THE PATIENT'S LEG WHEN THE POWER WAS ON. THE LESION WAS ROUGHLY THE SAME SIZE AS THE HYSTEROSCOPE TIP (4 - 5MM). ACCESSING THE ENDOMETRIAL CAVITY WAS DIFFICULT AND THE OPERATORS WERE SWITCHING BETWEEN USING THE HYSTEROSCOPE TO FACILITATE DILATATION, AND HEGAR DILATORS. WHEN THE HYSTEROSCOPE WAS NOT BEING ACTIVELY USED, IT WAS PLACED ON THE PATIENT'S ABDOMEN. THE CONSULTANT WOULD USUALLY ASK A MEMBER OF THE NURSING TEAM IN THEATRE TO TURN THE POWER OFF WHEN THE HYSTEROSCOPE IS NOT BEING ACTIVELY USED, BUT IN THIS CASE, POSSIBLY BECAUSE THERE WAS CONTINUAL SWITCHING BETWEEN MEANS OF DILATING THE CERVIX, THIS DOES NOT SEEM TO HAVE BEEN THE CASE. ONCE THE INJURY WAS IDENTIFIED, THE MEDICAL AND NURSING TEAMS INSPECTED THE DRAPES BUT FOUND NO EVIDENCE OF CHARRING OR BURNING. PATIENT ASSESSED AT THE BURNS CLINIC THE FOLLOWING DAY. THE BURN WAS FOUND TO BE FULL THICKNESS, AND THE PATIENT WENT TO SURGERY THERE FOR EXCISION AND PRIMARY CLOSURE OF THE LESION. SHE WAS DISCHARGED THE FOLLOW

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 9679558 ↗