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PANOVIEW 8626431Recalls & reported problems

Richard Wolf GmbH · CYSTOSCOPE 5° 9.5/11.5FR WL 116MM rigid, with lateral ocular lens, working channel 5Fr, atraumatic distal tip, TL 218mm, rod lens system · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207018064), received between Jul 8, 2020 and Oct 19, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Blocked Connection” (1 report).

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

  • Blocked Connection1
  • Material Fragmentation1
  • Material Separation1
  • Mechanical Problem1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 19, 2021Material Separation; Material Separation

    RICHARD WOLF RECEIVED A MEDWATCH REPORT FROM THE FDA. IT WAS REPORTED TO: "PHYSICIAN WAS DOING A CYSTOSCOPY ON THE PATIENT WITH A RICHARD WOLF (B)(4) PANOVIEW CYSTOSCOPE. PHYSICIAN NOTICED A FOREIGN BODY INSIDE THE BLADDER OF THE PATIENT. MEDICAL STAFF CHECKED AND THE SCOPE WAS MISSING ITS LENS COVER. THE SURGEON RETRIEVED THE LENS COVER BY USING A GRASPER. NO HARM TO THE PATIENT."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12656545 ↗
  • MalfunctionJul 21, 2020Mechanical Problem; Mechanical Problem

    IN (B)(6) 2020, RWMIC RECEIVED THE FOLLOWING COMPLAINT FROM THE USER FACILITY: BOTH SCOPES WERE USED IN SURGERY TODAY AND A CATHETER WAS NOT ABLE TO PASS THROUGH THEM SMOOTHLY. THE DEVICES WILL BE RETURN FOR EVALUATION. THE DEVICES WERE BEING USED ON THE PATIENT WHEN THE ISSUE OCCURRED BUT DID NOT CAUSE ANY INJURY OR ILLNESS TO THE PATIENT OR ANY OTHER PERSONNEL. THE ISSUE DID CAUSE A DELAY IN THE PROCEDURE BUT THE DELAY DID NOT PUT THE PATIENT AT RISK. THERE WAS A SIMILAR BACK UP DEVICE AND THE SCHEDULE PROCEDURE WAS COMPLETED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10301998 ↗
  • InjuryJul 8, 2020Material Fragmentation; Blocked Connection; Blocked Connection

    ON APRIL 20, 2020, RWMIC RECEIVED THE REPORT MW5094069. IN THE REPORT, THE INITIAL REPORTER DESCRIBED THE FOLLOWING EVENT OCCURRED DURING A PROCEDURE. DURING THE CYSTOSCOPY, IT WAS NOTED THAT THE OPEN-ENDED 5-FRENCH URETERAL CATHETER WAS BEING SHEARED BY THE SCOPE WHEN THE CATHETER WAS BEING WITHDRAWN. TWO SMALL SHAVING WERE IN THE BLADDER AS A RESULT OF THIS. THE FRAGMENTS FROM THE 5-FRENCH URETERAL CATHETER WERE IDENTIFIED AND REMOVED IN THEIR ENTIRETY.

    Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

    MAUDE report 10247467 ↗

Other CYSTOURETHROSCOPE devices

All CYSTOURETHROSCOPE devices →

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