SHARK 8675322Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04055207019641), received between Aug 30, 2018 and Sep 1, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543189 ↗
• MalfunctionAug 21, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE INFORMATION RECEIVED, THE TIP BROKE OFF DURING PROCEDURE. THE DOCTOR CONFIRMED THAT NO PIECES WERE IN THE BLADDER. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862032 ↗
• InjuryApr 15, 2024Material Fragmentation; Material Fragmentation

  A MEDICAL FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING AN INTERNAL SHEATH RESECTOSCOPE 22FR, PART ID: 8675322, LOT#: UNKNOWN. ACCORDING TO THE RECEIVED INFORMATION, DURING A LASER RESECTION THE RESECTOSCOPE CERAMIC TIP DETACHED INSIDE THE PATIENT. ALSO, NOTICED THE CERAMIC TIP DETACHING FROM THE INNER SHIRT OF THE GOWN. ALL PARTS WERE RECOVERED AND THE SCHEDULED PROCEDURE WAS SUCCESSFULLY COMPLETED. HOWEVER, THE OPERATION TIME WAS EXTENDED BY 40 MINUTES WHILE THE DOCTOR TRY AND REMOVED THE TIP. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19108208 ↗
• InjuryApr 15, 2024Material Fragmentation; Material Fragmentation

  A MEDICAL FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING AN INTERNAL SHEATH RESECTOSCOPE 22FR, PART ID: 8675322, LOT # 1225568. ACCORDING TO THE RECEIVED INFORMATION, DURING A LASER RESECTION THE RESECTOSCOPE CERAMIC TIP DETACHED INSIDE THE PATIENT. ALSO, NOTICED THE CERAMIC TIP DETACHING FROM THE INNER SHIRT OF THE GOWN. ALL PARTS WERE RECOVERED AND THE SCHEDULED PROCEDURE WAS SUCCESSFULLY COMPLETED. HOWEVER, THE OPERATION TIME WAS EXTENDED BY 40 MINUTES WHILE THE DOCTOR TRY AND REMOVED THE TIP. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19107480 ↗
• InjuryMar 8, 2024Material Fragmentation; Material Fragmentation

  A MEDICAL FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING AN INTERNAL SHEATH RESECTOSCOPE 22FR, PART ID: 8675322, LOT # 1537977. ACCORDING TO THE RECEIVED INFORMATION, DURING A LASER RESECTION THE RESECTOSCOPE CERAMIC TIP DETACHED INSIDE THE PATIENT. ALSO, NOTICED THE CERAMIC TIP DETACHING FROM THE INNER SHIRT OF THE GOWN. ALL PARTS WERE RECOVERED AND THE SCHEDULED PROCEDURE WAS SUCCESSFULLY COMPLETED. HOWEVER, THE OPERATION TIME WAS EXTENDED BY 40 MINUTES WHILE THE DOCTOR TRY AND REMOVED THE TIP. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869384 ↗
• MalfunctionJul 25, 2023Material Fragmentation; Material Fragmentation

  THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING AN INTERNAL SHEATH RESECTOSCOPE 22FR, PART ID: 8675322, LOT # 1511896. ACCORDING TO THE RECEIVED INFORMATION, THE CERAMIC SHEATH TIP (PART ID: 8675322) CAME OFF IN A PATIENT DURING A PROCEDURE. THE BROKEN PART WAS RETRIEVED. THE USER INFORMED THAT THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT, USER OR THIRD PARTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391239 ↗
• MalfunctionMay 22, 2023Material Fragmentation; Material Fragmentation

  THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING AN INTERNAL SHEATH RESECTOSCOPE 22FR, PART ID: 8675322, BATCH # 1457849. ACCORDING TO THE RECEIVED INFORMATION, THE BAKELITE (TIP) FELL INTO THE PATIENT DURING SURGERY. IT WAS PICKED UP BY THE SURGEON. THE INCIDENT OCCURRED IN THE END OF SURGERY. THERE WAS A REPORTED DELAY IN THE SURGERY. HOWEVER, NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16976952 ↗
• MalfunctionMar 16, 2023Material Fragmentation; Material Fragmentation

  A USER FACILITY REPRESENTATIVE HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A INTERNAL SHEATH RESECTOSCOPE 22FR, PART ID: 8675322, BATCH # 1511247. ACCORDING TO THE RECEIVED INFORMATION: "RESECTOR'S BLACK TIP (BAKELITE) CAME OFF DURING THE PROCEDURE, ENDING UP IN THE PATIENT'S BLADDER." THE TREATMENT WAS CONTINUED WITH ANOTHER PRODUCT AND COMPLETED WITH A DELAY OF ABOUT 30 MINUTES. THE USER INFORMED THAT THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT, USER OR THIRD PARTIES. THE BROKEN PART WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16559426 ↗
• MalfunctionApr 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO RICHARD WOLF BY THE SALES REP/USER FACILITY THAT THE INNER SHEATH TIP BROKE OFF WHILE BEING USED ON A PATIENT. THE TIP HAD TO BE REMOVED FROM WITHIN THE PATIENT. A REPLACEMENT SHEATH WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION REPORTED BY TUG SURGERGY STAFF (4/12/22 FROM SALES REP): PROCEDURE WAS DELAYED BY ABOUT 30 MINUTES DURING DELAY, THE SURGEON HAD TO TAKE TIME TO REMOVE THE SHEATH TIP THAT HAD COMPLETELY SEPARATED FROM THE DEVICE. THE SURGERY STAFF WENT OUT AND GET A BACK-UP TO BE USED TO COMPLETE PROCEDURE. PROCEDURE WAS COMPLETED, PATIENT OUTCOME IS FINE. ADDITIONAL INFORMATION: 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? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250689 ↗
• MalfunctionApr 29, 2022Material Separation; Material Separation

  IT WAS REPORTED TO RICHARD WOLF BY THE SALES REP/USER FACILITY THAT "THE INNER SHEATH TIP BROKE OFF WHILE BEING USED ON A PATIENT. THE TIP HAD TO BE REMOVED FROM WITHIN THE PATIENT. A REPLACEMENT SHEATH WAS USED TO COMPLETE THE PROCEDURE." ADDITIONAL INFORMATION REPORTED BY TUG SURGERY STAFF ((B)(6) 2022 FROM SALES REP): PROCEDURE WAS DELAYED BY ABOUT 30 MINUTES DURING DELAY, THE SURGEON HAD TO TAKE TIME TO REMOVE THE SHEATH TIP THAT HAD COMPLETELY SEPARATED FROM THE DEVICE. THE SURGERY STAFF WENT OUT AND GET A BACK-UP TO BE USED TO COMPLETE PROCEDURE. PROCEDURE WAS COMPLETED, PATIENT OUTCOME IS FINE. ADDITIONAL INFORMATION: 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? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250681 ↗
• MalfunctionOct 29, 2020Break; Break

  ON SEPTEMBER 28, 2020 RICHARD WOLF GMBH WAS INFORMED BY RICHARD WOLF FRANCE ABOUT AN ADVERSE EVENT. ON (B)(6) 2020, DURING THE SURGERY, THE CERAMIC TIP OF THE INTERNAL ROTATING SHEET CH24, "FELL INTO THE PATIENT." THE TIP HAS SEPARATED FROM THE STAINLESS STEEL SHEET. THE TIP NEITHER TWISTED NOR SPLIT. IT HAS "TAKEN OFF". THE ROTATING JACKET WAS PUT INTO SERVICE IN NOVEMBER 2016.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10758473 ↗
• MalfunctionApr 4, 2019Break; Break

  THE USER FACILITY RETURNED THE DEVICE TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) ON MAY 28, 2019 AND THE DEVICE EVALUATION WAS COMPLETED ON JUNE 14, 2019. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED, THE DISTAL TIP WAS OBSERVED TO BE BROKEN. THE CERAMIC TIP WAS MOST LIKELY CRACKED AT SOME POINT DURING PREVIOUS HANDLING, WHICH MAY HAVE RESULTED IN THE TIP DETACHING DURING THIS PROCEDURE. PROBABLE ROOT CAUSE WAS DETERMINED TO BE USER HANDLING ISSUES, A MANUFACTURING DEFECT WAS NOT IDENTIFIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8485319 ↗
• MalfunctionMar 8, 2019Material Fragmentation; Material Fragmentation

  ON (B)(6) 2018, THE USER FACILITY REPORTED THE FOLLOWING TO (B)(4): CERAMIC TIP BROKE INSIDE THE PATIENT AND FRAGMENTS HAD TO BE REMOVED. 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? UNKNOWN. THE DEVICE WAS VISUALLY EVALUATED AND APPEARED TO BE BROKEN - MISSING PIECES FROM THE CERAMIC TIP. PROBABLE ROOT CAUSE WAS DETERMINED TO BE USER ERROR / MISUSE, THE TIP MAY HAVE BEEN HIT DIRECTLY BY A LASER, CAUSING IT TO BURN AND THE FRAGMENTS TO BREAK OFF. THE DEVICE DID NOT MEET SPECIFICATIONS. A MANUFACTURING DEFECT WAS NOT IDENTIFIED. THE INSTRUMENT WAS REPAIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8405907 ↗
• MalfunctionAug 30, 2018Break; Material Fragmentation

  RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION, HEREINAFTER REFERRED TO AS RWMIC, WAS NOTIFIED VIA RWMIC SALES TEAM OF AN EVENT THAT OCCURRED DURING PATIENT PROCEDURE ON AN UNSPECIFIED DATE. IT WAS REPORTED THAT THE CERAMIC TIP BROKE OFF AND FRAGMENTED INTO THE PATIENT. THE CUSTOMER REPORTED THAT THIS OCCURRED WHEN USING A GREEN LIGHT LASER. THE SURGEON REMOVED THE PIECES. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7835343 ↗