HOPKINS 26120BARecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04048551093832), received between Jun 5, 2017 and Sep 9, 2026 — classified as 6 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (7 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697620 ↗
• MalfunctionJul 27, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50006432 ↗
• MalfunctionMay 13, 2026Poor Quality Image

  IT WAS REPORTED THAT "THE OUTPUT IS BLURRY AND CANNOT BE WHITE-BALANCED".

  Patient problems: Insufficient Information

  MAUDE report 25163482 ↗
• MalfunctionApr 7, 2026Device Reprocessing Problem; Optical Distortion

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

  Patient problems: Insufficient Information

  MAUDE report 24801206 ↗
• MalfunctionApr 2, 2026Optical Distortion

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

  Patient problems: Insufficient Information

  MAUDE report 24769771 ↗
• MalfunctionMar 17, 2026Poor Quality Image

  IT WAS REPORTED THAT THE IMAGE IS FOGGY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24623776 ↗
• MalfunctionMar 17, 2026Poor Quality Image

  IT WAS REPORTED THAT THE IMAGE IS FOGGY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24623775 ↗
• MalfunctionMar 7, 2026Poor Quality Image; Failure to Clean Adequately

  IT WAS REPORTED THAT "BAD IMAGE - BLACK DOTS, BLURRY. SCOPE HAS ONLY BEEN USED ONCE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24540583 ↗
• MalfunctionMar 2, 2026Poor Quality Image; Insufficient Device Problem Information

  IT WAS REPORTED THAT "THE UTERINE OFFICE HYSTEROSCOPE MODEL 26120BA PERFORMS POORLY WHEN IN USE. THE HYSTEROSCOPE HAS CRYSTAL FRACTURE AND BLURRED IMAGE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491914 ↗
• MalfunctionNov 10, 2025Break; Decoupling; Inadequate or Insufficient Training; Dent in Material; Improper Chemical Reaction; Break; Decoupling; Inadequate or Insufficient Training; Dent in Material; Improper Chemical Reaction

  IT HAS BEEN REPORTED: MAJOR DAMAGE, EXPOSED LIGHT FIBERS ON LIGHT POST. THE LIGHT HOOKS BROKE OFF FROM THE SCOPE NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23514632 ↗
• InjuryJun 24, 2025Device Reprocessing Problem; Corroded; Detachment of Device or Device Component; Material Deformation; Optical Problem; Failure to Clean Adequately; Poor Visibility; Device Reprocessing Problem; Corroded; Detachment of Device or Device Component; Material Deformation; Optical Problem; Failure to Clean Adequately; Poor Visibility

  IT WAS REPORTED THAT THE SCOPE HAD ERROR MESSAGE AND BLURRY IMAGE THAT DELAYED THE CASE FOR 45 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321992 ↗
• InjuryJun 24, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT THE SCOPE HAD ERROR MESSAGE AND BLURRY IMAGE THAT DELAYED THE CASE FOR 45 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22321991 ↗
• InjuryJun 24, 2025Device Reprocessing Problem; Corroded; Detachment of Device or Device Component; Material Deformation; Optical Problem; Failure to Clean Adequately; Poor Visibility; Device Reprocessing Problem; Corroded; Detachment of Device or Device Component; Material Deformation; Optical Problem; Failure to Clean Adequately; Poor Visibility

  IT WAS REPORTED THAT THE SCOPE HAD ERROR MESSAGE AND BLURRY IMAGE THAT DELAYED THE CASE FOR 45 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321990 ↗
• InjuryJun 24, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT THE SCOPE HAD ERROR MESSAGE AND BLURRY IMAGE THAT DELAYED THE CASE FOR 45 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22321989 ↗
• MalfunctionMay 15, 2025Crack; Decoupling; Inadequate or Insufficient Training; Dent in Material; Improper Chemical Reaction; Crack; Decoupling; Inadequate or Insufficient Training; Dent in Material; Improper Chemical Reaction

  IT WAS REPORTED THE LENS IS CRACKED AND THE VISIBILITY HAS DIMINISHED DURING MEDICAL PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031469 ↗
• MalfunctionMay 15, 2025Crack; Material Integrity Problem; Crack; Material Integrity Problem

  IT WAS REPORTED THE LENS IS CRACKED AND THE VISIBILITY HAS DIMINISHED DURING MEDICAL PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031464 ↗
• InjuryJan 28, 2025Break; Break

  IT WAS REPORTED DURING A MEDICAL PROCEDURE ON (B)(6) 2024, THE PHYSICIAN WAS TRYING TO GET THE PRODUCT THROUGH THE CERVIX AND THE SCOPE BROKE. THE HYSTEROSCOPE SHEATH AND HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM WERE ATTACHED (BOTH INSTRUMENTS WERE BEING USED DURING THE PROCEDURE). IT WAS REPORTED DURING THE HYSTEROSCOPY PROCEDURE WAS PROLONGED FOR 30 MINUTES ON (B)(6), 2024, THE SURGEON WAS NOT ABLE TO COMPLETE THE PROCEDURE, THE PATIENT WAS REFERRED TO GYN CROSS REFERENCE MDR: 9610617-2025-00025.

  Patient problems: Insufficient Information

  MAUDE report 21261286 ↗
• InjuryJan 14, 2025Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED DURING A MEDICAL PROCEDURE ON (B)(6) 2024, THE PHYSICIAN WAS TRYING TO GET THE PRODUCT THROUGH THE CERVIX AND THE SCOPE BROKE. THE HYSTEROSCOPE SHEATH AND HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM WERE ATTACHED (BOTH INSTRUMENTS WERE BEING USED DURING THE PROCEDURE). IT WAS NOT REPORTED IF THERE WAS ANY HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER MULTIPLE ATTEMPTS. CROSS REFERENCE MDR: 9610617-2025-00025.

  Patient problems: Insufficient Information

  MAUDE report 21150654 ↗
• MalfunctionJun 5, 2017Material Fragmentation; Material Fragmentation

  THIS IS A SUPPLEMENTAL. I WILL BE ADDING METHOD/RESULTS/CONCLUSION CODES AND EVALUATION OF THE INSTRUMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 6613568 ↗