PANOVIEW PLUS HD 892109205Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04055207035115), received between Dec 20, 2018 and May 13, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Poor Quality Image

  IT WAS REPORTED THAT DURING A PROCEDURE, THE IMAGE ON THE SCOPE BECAME BLURRY, MAKING VISUALIZATION UNCLEAR. DUE TO IT, THE PROCEDURE WAS PROLONGED BY AN HOUR. AS THE PROCEDURE WAS ALMOST COMPLETED, THE DOCTOR DECIDED NOT TO CONVERT IT TO ANOTHER METHOD. AFTER THE PROCEDURE, THE SCOPE WAS INSPECTED AND FOUND THAT IT HAS WATER LEAKAGE. IT WAS REPORTED THAT THE SCOPE HAS BEEN USED MULTIPLE TIMES. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164754 ↗
• InjuryApr 30, 2026Partial Blockage

  IT WAS REPORTED THAT DURING A PLANNED FULL ENDOSCOPIC STENOSIS DECOMPRESSION (TWO LEVELS) PROCEDURE, THE WORKING CHANNEL IS "PARTIALLY BLOCKED". KERRISON RONGEUR (PUNCHES) AND HIGH-SPEED BURR CANNOT PASS THROUGH THE CHANNEL. ALTHOUGH, NO FOREIGN BODY WAS BLOCKING THE CHANNEL, IT WAS FOUND THAT THE WORKING CHANNEL WAS TRIANGULARLY SHAPED. THE SURGEON HAD TO CHANGE THE SURGICAL PROCEDURE TO A MINOR SURGERY AND USE A MICROSCOPE IN THE END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046940 ↗
• MalfunctionOct 4, 2022Leak/Splash; Optical Obstruction; Leak/Splash; Optical Obstruction

  RWMIC REFERENCE COMPLAINT NO. (B)(4). ON (B)(6) 2022, IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY A USER FACILITY REPRESENTATIVE REGARDING PRODUCT ID# 892109205, (B)(4). "THIS NEWLY RECEIVED REPAIR EXCHANGE SCOPE LEAKS IRRIGATION AROUND THE FORWARD SEAL." ADDITIONAL INFORMATION REPORTED BY THE USER FACILITY REPRESENTATIVE: (EMAIL, DATED (B)(6) 2022) THIS ISSUE WAS DISCOVERED IN THE OPERATING ROOM. THE SCOPE WAS LEAKING IRRIGATION FLUID FROM THE REAR SEAL AT ALL PRESSURE LEVELS, SUCH THAT THE SET IRRIGATION PRESSURE COULD NOT BE MAINTAINED EVEN WITH EXCESSIVE FLOW. THIS RESULTED IN POOR SURGICAL VISIBILITY AND CONSUMPTION OF 36 LITERS OF IRRIGATION ON A CASE THAT WOULD NORMALLY TAKE 12-15 LITERS. CASE WAS COMPLETED AND THERE WAS NO PATIENT INJURY AS A RESULT." COMPLAINT DATA COLLECTION QUESTIONNAIRE REPAIR CUSTOMER SERVICE: WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? Y

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540234 ↗
• MalfunctionOct 4, 2022Leak/Splash; Optical Obstruction; Leak/Splash; Optical Obstruction

  RWMIC REFERENCE COMPLAINT NO. (B)(4). ON (B)(6) 2022, IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY A USER FACILITY REPRESENTATIVE REGARDING PRODUCT ID# 892109205, (B)(4). "THIS NEWLY RECEIVED REPAIR EXCHANGE SCOPE LEAKS IRRIGATION AROUND THE FORWARD SEAL." ADDITIONAL INFORMATION REPORTED BY THE USER FACILITY REPRESENTATIVE: (EMAIL, DATED SEPTEMBER 19, 2022) THIS ISSUE WAS DISCOVERED IN THE OPERATING ROOM. THE SCOPE WAS LEAKING IRRIGATION FLUID FROM THE REAR SEAL AT ALL PRESSURE LEVELS, SUCH THAT THE SET IRRIGATION PRESSURE COULD NOT BE MAINTAINED EVEN WITH EXCESSIVE FLOW. THIS RESULTED IN POOR SURGICAL VISIBILITY AND CONSUMPTION OF 36 LITERS OF IRRIGATION ON A CASE THAT WOULD NORMALLY TAKE 12-15 LITERS. THE CASE WAS COMPLETED AND THERE WAS NO PATIENT INJURY AS A RESULT." WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? NO. WAS THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540214 ↗
• MalfunctionOct 4, 2022Leak/Splash; Optical Obstruction; Leak/Splash; Optical Obstruction

  RWMIC REFERENCE COMPLAINT NO. (B)(4). ON (B)(6) 2022, IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY A USER FACILITY REPRESENTATIVE REGARDING PRODUCT ID# 892109205, (B)(4). "THIS NEWLY RECEIVED REPAIR EXCHANGE SCOPE LEAKS IRRIGATION AROUND THE FORWARD SEAL." ADDITIONAL INFORMATION REPORTED BY THE USER FACILITY REPRESENTATIVE: (EMAIL, DATED (B)(6) 2022) THIS ISSUE WAS DISCOVERED IN THE OPERATING ROOM. THE SCOPE WAS LEAKING IRRIGATION FLUID FROM THE REAR SEAL AT ALL PRESSURE LEVELS, SUCH THAT THE SET IRRIGATION PRESSURE COULD NOT BE MAINTAINED EVEN WITH EXCESSIVE FLOW. THIS RESULTED IN POOR SURGICAL VISIBILITY AND CONSUMPTION OF 36 LITERS OF IRRIGATION ON A CASE THAT WOULD NORMALLY TAKE 12-15 LITERS. THE CASE WAS COMPLETED AND THERE WAS NO PATIENT INJURY AS A RESULT." WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? NO. WAS THERE A SI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540123 ↗
• MalfunctionOct 4, 2022Leak/Splash; Optical Obstruction; Leak/Splash; Optical Obstruction

  RWMIC REFERENCE COMPLAINT NO. (B)(4). THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540108 ↗
• MalfunctionDec 20, 2018Poor Quality Image; Optical Problem; Poor Quality Image; Optical Problem

  FOLLOW UP #1 TO PROVIDE INVESTIGATION RESULTS TO FDA. USER FACILITY RETURNED THE DEVICE TO RWMIC ON DECEMBER 05, 2018, AND WAS SENT TO THE MANUFACTURER FOR EVALUATION. THE EVALUATION WAS COMPLETED ON JANUARY 25, 2019. THE DEVICE APPEARED TO BE USED - THERE WAS MOISTURE IN THE OPTICAL SYSTEM AND NO LEAKAGE ON THE OPTIC COULD BE FOUND. THE REPORTED CONDITION WAS VERIFIED USING VISUAL AND FUNCTIONAL TESTING. THERE WERE NO SIGNS OF FALSE HANDLING BY THE USER. AS NO LEAKAGE ON THE OPTIC COULD BE FOUND, IT WAS UNCLEAR HOW THE MOISTURE COULD PENETRATE INTO THE OPTICAL SYSTEM. THE INSTRUMENT DID NOT MEET SPECIFICATIONS AND A MANUFACTURING DEFECT WAS NOT IDENTIFIED. THE INSTRUMENT WAS REPAIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8187144 ↗