PANOVIEW PLUS 8986402Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04055207023686), received between Aug 29, 2019 and Jun 3, 2024 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2024Poor Quality Image; Poor Quality Image

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A HYSTEROSCOPE 30° Ø 3.9MM WL 217MM, PART ID: 8986402, SERIAL # (B)(6). ACCORDING TO THE USER FACILITY, EVERY TIME THE SCOPE IS USED, IT GETS FOGGY AND THE IMAGE IS POOR. WHEN THE HYSTEROSCOPE IS INSERTED INTO THE PATIENT, THE LENS BECAME CLOUDY IMMEDIATELY AT THE BEGINNING OF THE PROCEDURE. PREVENTING ADEQUATE VISUALIZATION OF THE DIAGNOSTIC AND OPERATIVE FIELD. IT APPEARS MOISTURE CONDENSES ON THE INNER SIDE OF THE LENS. THE ENTIRE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19452486 ↗
• InjuryJul 10, 2023Poor Quality Image; Poor Quality Image

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A HYSTEROSCOPE 30° Ø 3.9MM WL 217MM, PART ID: 8986402, SERIAL # (B)(6). ACCORDING TO THE USER FACILITY, "THE FIRST HYSTEROSCOPE WAS CLEAR AND THE FIBEROPTICS LOOK GOOD. WHEN INSERTED INTO THE PATIENT AND TURNED ON THE WATER FLOW, THE VISUAL FIELD BECAME FOGGY. THE PROVIDER TRIED TO USE A SECOND SCOPE AND HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH THE SECOND HYSTEROSCOPE AS THE VISUAL FIELD WAS NOT AS IMPAIRED AS IN THE FIRST SCOPE." IN ADDITION, THE REPORTED ISSUE CAUSED A 30 MINUTE DELAY DURING A DIAGNOSTIC HYSTEROSCOPY PROCEDURE WHILE TRYING TO RESOLVE THE ISSUE WITH THE SCOPE, RETRIEVE THE BACK-UP DEVICE, AND TRY TO RESOLVE THE SAME ISSUE WITH THE BACK-UP SCOPE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287043 ↗
• InjuryJul 10, 2023Poor Quality Image; Poor Quality Image

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A HYSTEROSCOPE 30° Ø 3.9MM WL 217MM, PART ID: 8986402, SERIAL # (B)(6). ACCORDING TO THE USER FACILITY, "THE FIRST HYSTEROSCOPE WAS CLEAR AND THE FIBEROPTICS LOOK GOOD. WHEN INSERTED INTO THE PATIENT AND TURNED ON THE WATER FLOW, THE VISUAL FIELD BECAME FOGGY. THE PROVIDER TRIED TO USE A SECOND SCOPE AND HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH THE SECOND HYSTEROSCOPE AS THE VISUAL FIELD WAS NOT AS IMPAIRED AS IN THE FIRST SCOPE." IN ADDITION, THE REPORTED ISSUE CAUSED A 30 MINUTE DELAY DURING A DIAGNOSTIC HYSTEROSCOPY PROCEDURE WHILE TRYING TO RESOLVE THE ISSUE WITH THE SCOPE, RETRIEVE THE BACK-UP DEVICE, AND TRY TO RESOLVE THE SAME ISSUE WITH THE BACK-UP SCOPE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286914 ↗
• InjuryJul 7, 2023Poor Quality Image; Poor Quality Image

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A HYSTEROSCOPE 30° Ø 3.9MM WL 217MM, PART ID: 8986402, SERIAL # (B)(6). ACCORDING TO THE USER FACILITY, "THE FIRST HYSTEROSCOPE WAS CLEAR AND THE FIBEROPTICS LOOK GOOD. WHEN INSERTED INTO THE PATIENT AND TURNED ON THE WATER FLOW, THE VISUAL FIELD BECAME FOGGY. THE PROVIDER TRIED TO USE A SECOND SCOPE AND HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH THE SECOND HYSTEROSCOPE AS THE VISUAL FIELD WAS NOT AS IMPAIRED AS IN THE FIRST SCOPE." IN ADDITION, THE REPORTED ISSUE CAUSED A 30 MINUTE DELAY DURING A DIAGNOSTIC HYSTEROSCOPY PROCEDURE WHILE TRYING TO RESOLVE THE ISSUE WITH THE SCOPE, RETRIEVE THE BACK-UP DEVICE, AND TRY TO RESOLVE THE SAME ISSUE WITH THE BACK-UP SCOPE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17282708 ↗
• InjuryJul 7, 2023Poor Quality Image; Poor Quality Image

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A HYSTEROSCOPE 30° Ø 3.9MM WL 217MM, PART ID: 8986402, LOT #: (B)(6). ACCORDING TO THE USER FACILITY, "THE FIRST HYSTEROSCOPE WAS CLEAR AND THE FIBEROPTICS LOOK GOOD. WHEN INSERTED INTO THE PATIENT AND TURNED ON THE WATER FLOW, THE VISUAL FIELD BECAME FOGGY. THE PROVIDER TRIED TO USE A SECOND SCOPE AND HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH THE SECOND HYSTEROSCOPE AS THE VISUAL FIELD WAS NOT AS IMPAIRED AS IN THE FIRST SCOPE." IN ADDITION, THE REPORTED ISSUE CAUSED A 30 MINUTE DELAY DURING A DIAGNOSTIC HYSTEROSCOPY PROCEDURE WHILE TRYING TO RESOLVE THE ISSUE WITH THE SCOPE, RETRIEVE THE BACK-UP DEVICE, AND TRY TO RESOLVE THE SAME ISSUE WITH THE BACK-UP SCOPE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17282192 ↗
• MalfunctionMay 31, 2022Optical Problem; Optical Problem

  IT WAS REPORTED TO RICHARD WOLF THAT "WHEN USING THE SCOPE IT BECAME HAZY AND HARD TO SEE THRU. THIS HAS HAPPENED BEFORE AND THE CUSTOMER WOULD LIKE TO KNOW WHY IT KEEPS HAPPENING. NO PATIENT INJURY. CASE WAS COMPLETED." ADDITIONAL INFORMATION FROM THE USER FACILITY: "WHILE DOING HYSTEROSCOPY THE LENS GOT HAZY AND IT WAS HARD TO SEE. THE PICTURE WAS NOT CLEAR HOWEVER WE WERE ABLE TO SEE ENOUGH TO FINISH PROCEDURE." WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. HOW WAS THE PATIENT ANESTHETIZED? GENERAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14552717 ↗
• MalfunctionNov 10, 2020Break; Material Fragmentation; Break; Material Fragmentation

  DEVICE EVALUATION (B)(6) 2021. FINDINGS: ACCORDING TO OUR TEST INSTRUCTION 8986402 PA WE FOUND: A) THE DISTAL PART OFTHE CLADDING TUBE IS HEAVILY CRUSHED AND BENT UP. LT IS HIGHLY PROBABLE THAT A PIECE HAS COME LOOSE AT THE EDGE OFTHE DISTAL CLADDING TUBE. B) THE CLADDING TUBE IS BENT. C) DISTAL LIGHT END SURFACE IS OVERHEATED AND POROUS. A, B) THE HYSTEROSCOPE GETS DAMAGED BY MECHANICAL INTLUENCES/ OVERLOAD (CUSTOMER FAULT). C) THE CAUSE OF DAMAGE IS DUE TO INSUFFICIENT CLEANING AND CARE OF THE DISTAL LIGHT-EMITTING SURFACE. THE USER IS INFORMED IN THE IFU GA-E200 CHAPTER 7.2 AND IN THE APPLICABLE GA-1020 TO CLEAN THE GLASS LIGHT-EMITTING SURFACES WITH A COTTON SWAB SOAKED IN ALCOHOL, AS THIS CONSIDERABLY WORSENS THE LIGHT TRANSMISSION. THE DEVICE DOES NOT MEET THE SPECIFICATIONS AND THE REPORTED CONDITIONS WERE CONFIRMED DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10818075 ↗
• MalfunctionAug 29, 2019Optical Problem; Appropriate Device Problem Term/Code Not Available; Optical Problem; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2019, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): WHEN USING THE SCOPES, THEY BECOME HAZY AND HARD TO SEE THROUGH. NO PATIENT INJURY, CASE WAS COMPLETED. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. HOW WAS THE PATIENT ANESTHETIZED? GENERAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8947567 ↗
• MalfunctionAug 29, 2019Optical Problem; Appropriate Device Problem Term/Code Not Available; Optical Problem; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2019, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): WHEN USING THE SCOPES, THEY BECOME HAZY AND HARD TO SEE THROUGH. NO PATIENT INJURY, CASE WAS COMPLETED. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES HOW WAS THE PATIENT ANESTHETIZED? GENERAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8947566 ↗