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PANOVIEW 8974402Recalls & reported problems

Richard Wolf GmbH · TELESCOPE 30° Ø 2.7MM SL 310MM rigid, TL 370mm, rod lens system · Class 2

Adverse event reports
5
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04055207023600), received between Feb 10, 2017 and Feb 21, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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

Device problems

  • Crack2
  • Fracture2
  • Moisture or Humidity Problem2
  • Optical Obstruction2
  • Device Handling Problem1
  • Material Deformation1

Patient problems

  • Discomfort2
  • Hemorrhage/Blood Loss/Bleeding2
  • Insufficient Information2
  • Intraoperative Pain2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 21, 2023Moisture or Humidity Problem; Optical Obstruction; Moisture or Humidity Problem; Optical Obstruction

    THE USER FACILITY REPRESENTATIVE REPORTED REGARDING TELESCOPE 30° Ø 2.7MM SL 310MM, PART # 8974402, SN. (B)(4). "THE SCOPE WAS UNCLEAR DURING A PROCEDURE AND COULD NOT SEE, SO THE DR. STOPPED THE PROCEDURE". ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY REPRESENTATIVE ON JANUARY 27, 2023. ACCORDING TO THE RECEIVED INFORMATION, THE SCHEDULED PROCEDURE WAS NOT COMPLETED, THE USER STOPPED THE PROCEDURE DUE TO IMAGE LOSS. A FOLLOW-UP PROCEDURE IS NECESSARY TO COMPLETE THE PLANNED TREATMENT.

    Patient problems: Insufficient Information

    MAUDE report 16409159 ↗
  • MalfunctionFeb 21, 2023Moisture or Humidity Problem; Optical Obstruction; Moisture or Humidity Problem; Optical Obstruction

    THE USER FACILITY REPRESENTATIVE REPORTED REGARDING TELESCOPE 30° Ø 2.7MM SL 310MM, PART # 8974402, SN. (B)(4). "THE SCOPE WAS UNCLEAR DURING A PROCEDURE AND COULD NOT SEE, SO THE DR. STOPPED THE PROCEDURE." ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY REPRESENTATIVE ON JANUARY 27, 2023. ACCORDING TO THE RECEIVED INFORMATION, THE SCHEDULED PROCEDURE WAS NOT COMPLETED, THE USER STOPPED THE PROCEDURE DUE TO IMAGE LOSS. A FOLLOW-UP PROCEDURE IS NECESSARY TO COMPLETE THE PLANNED TREATMENT.

    Patient problems: Insufficient Information

    MAUDE report 16409158 ↗
  • InjuryAug 25, 2022Crack; Fracture; Crack; Fracture

    RWMIC REFERENCE COMPLAINT NO. (B)(4). ON (B)(6) 2022, IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY A SALES REPRESENTATIVE/RWMIC THAT THE REPORTED DEVICE HAS "CRACKED LENS." INITIAL INFORMATION REPORTED BY THE USER FACILITY REPRESENTATIVE: (RICHARD WOLF MEDICAL INSTRUMENTS, REPAIR RETURN AUTHORIZATION NO. (B)(4), DATED (B)(6) 2022) "SCOPE WAS INSERTED IN PATIENT WHEN HAIR "LIKE" CRACK NOTICED ON LENS. PATIENT'S PROCEDURE TOOK LONGER. PATIENT DID EXPERIENCE MORE DISCOMFORT BUT WAS NOT INJURED." UPDATED INFORMATION RECEIVED: (EMAIL, 08/04/2022) 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 SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. ON (B)(6) 2022, ADDITIONAL DETAILS WERE PROVIDED BY THE INITIAL REPORTER (REPAIR RETURN AUTHORIZATION NO. (B)(4) STATING "THE PROCEDURE WAS

    Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Intraoperative Pain

    MAUDE report 15296482 ↗
  • InjuryAug 25, 2022Crack; Fracture; Crack; Fracture

    RWMIC REFERENCE COMPLAINT NO. (B)(4). ON (B)(6) 2022, IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY A SALES REPRESENTATIVE/RWMIC THAT THE REPORTED DEVICE HAS "CRACKED LENS." INITIAL INFORMATION REPORTED BY THE USER FACILITY REPRESENTATIVE: (RICHARD WOLF MEDICAL INSTRUMENTS, REPAIR RETURN AUTHORIZATION NO. 200422956, DATED (B)(6) 2022) "SCOPE WAS INSERTED IN PATIENT WHEN HAIR "LIKE" CRACK NOTICED ON LENS. PATIENT'S PROCEDURE TOOK LONGER. PATIENT DID EXPERIENCE MORE DISCOMFORT BUT WAS NOT INJURED." UPDATED INFORMATION RECEIVED: (EMAIL, (B)(6) 2022). 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 SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. ON 09-AUG- 2022, ADDITIONAL DETAILS WERE PROVIDED BY THE INITIAL REPORTER (REPAIR RETURN AUTHORIZATION NO. 200422956) STATING "THE PRO

    Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Intraoperative Pain

    MAUDE report 15296429 ↗
  • MalfunctionFeb 10, 2017Material Deformation; Device Handling Problem; Material Deformation; Device Handling Problem

    FOLLOW UP #1

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6321640 ↗

Other Resectoscope devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.