PANOVIEW 8650415Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207018354), received between Sep 13, 2019 and Sep 14, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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, THE "PROXIMAL" WAS LEAKING, AND THE OBJECTIVE WAS DAMAGED FROM MOISTURE. 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? (SEE IFU GA-S001 SECTION 8.2)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9056752 ↗
• 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 # 8650.415, SERIAL # (B)(4). AS THE DEVICE HAD ALREADY BEEN CLEANED PRIOR TO LEAVING THE RECEIVING DEPARTMENT, NO RESIDUE COULD BE DETECTED. THE SCOPE PRESENTED DAMAGE THAT MAY HAVE BEEN DUE TO A THIRD PARTY REPAIR, CUSTOMER CONFIRMED THE DEVICE HAD BEEN REPAIRED BY A THIRD PARTY. 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? (SEE IFU GA-S001 SECTION 8.2) ONLY FUNCTION BEFORE PLACING IN PAN TO BE STERILIZED, SPD PERSONNEL LOOK THROUGH THE SCOPE, SURGICAL TECHS IN THE OR DO NO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9050571 ↗
• 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 # 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 ONE (1) OF THE LENS WAS FOUND TO BE BROKEN. ADDITIONALLY, THE EYEPIECE AND COLOR RING WERE THIRD PARTY PARTS, 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 B

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9050517 ↗