PANOVIEW 8654422Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04055207018798), received between Sep 13, 2019 and Aug 19, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A PROSTATE RESECTION PROCEDURE USING A BIPOLAR RESECTOSCOPE AND AN ERBE VIO 300D GENERATOR, THE SURGEON OBSERVED A STRONG ELECTROLYTIC REACTION AT THE BEGINNING OF THE PROCEDURE. THE PATIENT SUFFERED SUDDEN HYPOCAPNIA, SEVERE GAS EMBOLISM, AND THREE CARDIAC ARRESTS. THE PATIENT IS CURRENTLY IN INTENSIVE CARE WITH SEVERE BRAIN DAMAGE.

  Patient problems: Air Embolism; Brain Injury; Cardiac Arrest; Electrolyte Imbalance; Hyperventilation

  MAUDE report 22839667 ↗
• MalfunctionOct 27, 2021Use of Device Problem; Device Handling Problem; Positioning Failure; Use of Device Problem; Device Handling Problem

  PLEASE SEE MANUFACTURERS NARRATIVE FOR DEVICE EVALUATION/INVESTIGATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705292 ↗
• MalfunctionOct 1, 2021Material Opacification; Material Opacification

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE EVALUATION. PLEASE SEE MANUFACTURERS NARRATIVE.

  Patient problems: Insufficient Information

  MAUDE report 12562567 ↗
• MalfunctionSep 14, 2019Failure to Clean Adequately; Failure to Clean Adequately

  ON JULY 11, 2019, A CUSTOMER REQUESTED FIVE (5) SCOPES BE RETURNED TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) FOR REPAIR. THE CUSTOMER REPORTED THAT A SUBSTANCE WAS BEING COOKED AT THE END AND REQUESTED TO KNOW WHAT THE SUBSTANCE WAS. THE DEVICES WERE RETURNED TO RWMIC ON JULY 16, 2019. UPON RETURN, PHOTOGRAPHS WERE TAKEN OF THE SCOPES. PHOTOGRAPHS SHOWED WAS APPEARED TO BE BLOOD AND TISSUE COOKED ON 4 OUT OF 5 OF THE SCOPE'S DISTAL TIPS. A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED FOR TELESCOPE PART # 8650.415, SERIAL # (B)(4). AS THE DEVICE HAD ALREADY BEEN CLEANED PRIOR TO LEAVING THE RECEIVING DEPARTMENT, NO RESIDUE COULD BE DETECTED. THE HOUSING WAS FOUND TO BE BENT AND DENTED AND THE NEGATIVE WAS CHIPPED. ADDITIONALLY, THE EYEPIECE WAS NOTED TO BE A THIRD PARTY PART, CUSTOMER CONFIRMED THE DEVICE HAD BEEN REPAIRED BY A THIRD PARTY. PROBABLE ROOT CAUSE WAS DETERMINED TO BE USER ERROR/MISUSE AND/OR USER HANDLING; THE DEVICE MAY HAVE BEEN EXPOSED TO SOME KIND OF PHYSICAL FORCE AND/OR THE DAMAGE MAY HAVE DUE TO THE THIRD PARTY REPAIR. ON JULY 14, 2019, THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WHAT KIND OF PROCEDURES WERE BEING PERFORMED WITH T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9056746 ↗
• MalfunctionSep 13, 2019Failure to Clean Adequately; Failure to Clean Adequately

  ON JULY 11, 2019, A CUSTOMER REQUESTED FIVE (5) SCOPES BE RETURNED TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) FOR REPAIR. THE CUSTOMER REPORTED THAT A SUBSTANCE WAS BEING COOKED AT THE END AND REQUESTED TO KNOW WHAT THE SUBSTANCE WAS. THE DEVICES WERE RETURNED TO RWMIC ON JULY 16, 2019. UPON RETURN, PHOTOGRAPHS WERE TAKEN OF THE SCOPES. PHOTOGRAPHS SHOWED WAS APPEARED TO BE BLOOD AND TISSUE COOKED ON 4 OUT OF 5 OF THE SCOPE'S DISTAL TIPS. A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED FOR TELESCOPE PART # 8654.422, SERIAL #: (B)(4). AS THE DEVICE HAD ALREADY BEEN CLEANED PRIOR TO LEAVING THE RECEIVING DEPARTMENT, NO RESIDUE COULD BE DETECTED. THE HOUSING WAS FOUND TO BE BENT AND DENTED, THE "PROXIMAL" WAS LEAKING, AND THE OBJECTIVE WAS CHIPPED. PROBABLE ROOT CAUSE WAS DETERMINED TO BE USER ERROR/MISUSE AND/OR USER HANDLING; THE DEVICE MAY HAVE BEEN EXPOSED TO SOME KIND OF PHYSICAL FORCE. ON JULY 14, 2019, THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WHAT KIND OF PROCEDURES WERE BEING PERFORMED WITH THESE DEVICES? CYSTOSCOPE CASES. DO YOU HAVE ANY EVIDENCE OF A FUNCTIONAL TEST PRIOR TO USING THESE INSTRUMENTS? ONLY FUNCTION BEFORE PLACING IN PAN TO BE S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9050423 ↗