SHARKRecalls & reported problems across all models
Richard Wolf GmbH · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 62
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 0
We found 10 models of SHARK by Richard Wolf GmbH in the FDA's device registry (GUDID). Together they are named in 62 adverse event reports in the FDA's MAUDE database, received between Aug 13, 2018 and Sep 16, 2026 — classified as 14 injuries, 48 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (32 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SHARK problems
Device problems
- Material Fragmentation32
- Break15
- Material Separation7
- Detachment of Device or Device Component6
- Insufficient Device Problem Information5
- Fire2
- Peeled/Delaminated2
- Temperature Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Insufficient Information18
- Foreign Body In Patient7
- No Known Impact Or Consequence To Patient6
- No Consequences Or Impact To Patient5
- Hemorrhage/Blood Loss/Bleeding2
- Abdominal Pain1
- Device Embedded In Tissue or Plaque1
SHARK models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SHARK 8675324RESECTOSCOPE27 reports
- SHARK 8675322RESECTOSCOPE14 reports
- SHARK 46782425ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL6 reports
- SHARK 8676424RESECTOSCOPE4 reports
- SHARK 46782435ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL4 reports
- SHARK 8675426RESECTOSCOPE2 reports
- SHARK 8674225RESECTOSCOPE, WORKING ELEMENT2 reports
- SHARK 8673022RESECTOSCOPE1 report
- SHARK 46782201ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 report
- SHARK 46782225ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 report
Recent SHARK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Material Fragmentation
Patient problems: Insufficient Information
MAUDE report 50794841 ↗MalfunctionSep 16, 2026Material Fragmentation
Patient problems: Insufficient Information
MAUDE report 50794812 ↗MalfunctionSep 1, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543189 ↗MalfunctionDec 11, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE HOLEP (HOLMIUM LASER ENUCLEATION OF THE PROSTATE) PROCEDURE, THE CERAMIC TIP BROKE OFF INSIDE THE PATIENT. THE SURGERY WAS ONLY EXTENDED BY 20 MINUTES BY RETRIEVING THE BROKEN PIECE, AND THE BROKEN CERAMIC TIP WAS RECOVERED SUCCESSFULLY. THE SCHEDULED PROCEDURE WAS COMPLETED.
Patient problems: Insufficient Information
MAUDE report 23780063 ↗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 ↗MalfunctionJul 18, 2025Break; Break
IT WAS REPORTED THAT DURING A LASER ENUCLEATION OF THE PROSTATE, THE INNER SHAFT BROKE OFF. THE OPERATION WAS COMPLETED WITHOUT HARM TO THE PATIENT AND WITHOUT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22542248 ↗MalfunctionJul 18, 2025Break; Break
IT WAS REPORTED THAT DURING A LASER ENUCLEATION OF THE PROSTATE, THE INNER SHAFT BROKE OFF. THE OPERATION WAS COMPLETED WITHOUT HARM TO THE PATIENT AND WITHOUT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22541806 ↗InjuryJul 14, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A MONOPOLAR TRANSURETHRAL RESECTION OF PROSTATE, THE CERAMIC TIP DETACHED. THE SURGERY WAS UNABLE TO BE COMPLETED.
Patient problems: Foreign Body In Patient
MAUDE report 22495864 ↗MalfunctionJun 25, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE URETEROSCOPY WITH TUMOR ABLATION, THE CERAMIC TIP BROKE OFF INSIDE THE PATIENT'S BLADDER. THE REPORTED ISSUE CAUSED AN HOUR DELAY IN THE PROCEDURE WHILE TROUBLESHOOTING HOW TO RETRIEVE THE PIECE OUT OF THE PATIENT. THE PHYSICIAN USED A LASER AND STONE BASKET TO REMOVE THE FRAGMENTS. THE DELAY DID NOT CAUSE ANY INJURIES OR UNACCEPTABLE CLINICAL RISKS TO THE PATIENT OR OTHER PERSONNEL, AND THE SCHEDULED PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: Foreign Body In Patient
MAUDE report 22330542 ↗MalfunctionMar 19, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE ENDOSCOPIC ENUCLEATION OF A PROSTATIC ADENOMA, ONCE THE RESECTOSCOPE WAS INSERTED THROUGH THE VESICAL NECK, THE DISTAL PORTION OF THE URETHRAL MEMBRANE IN CERAMIC WAS DETACHED. THERE WAS A BRIEF INTERRUPTION IN THE PROCEDURE FOR THE REMOVAL OF THE DISTAL DETACHMENT WHICH WAS EXTRACTED WITH DIFFICULTY BY ENDOSCOPIC FORCEPS." ACCORDING TO THE USER, THE BROKEN PIECE WAS COMPLETELY REMOVED, AND THE PROCEDURE COULD BE COMPLETED WITHOUT ANY CLINICALLY RELEVANT DELAY IN SURGERY. THE MEDICAL PURPOSE OF THE APPLICATION WAS FULFILLED AND THERE WAS NO DANGER FOR THE PATIENT, THE USER OR THIRD PARTIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21644464 ↗MalfunctionMar 3, 2025Material Fragmentation; Material Fragmentation
ACCORDING TO THE RECEIVED INFORMATION, "DR. WAS USING THE RESECTION SCOPE FOR A TRANSURETHRAL RESECTION OF PROSTATE PROCEDURE. ABOUT 5 MINUTES INTO RESECTING, THE TIP OF THE SHEATH BROKE OFF INTO THE PATIENT'S BLADDER. THE SURGEON SAFELY REMOVED THE TIP FROM THE BLADDER AND NO INJURY WAS NOTED.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21509615 ↗InjuryFeb 10, 2025Material Fragmentation; Material Fragmentation
ACCORDING TO THE RECEIVED INFORMATION, "DURING THE OPERATION, PART OF THE INSERTION TIP OF THE OBTURATOR BROKE OFF / SHATTERED IN THE URINARY BLADDER. " DURING THE RETRIEVAL, THE TIP PARTS WERE CUT / DIVIDED AGAIN BY THE SURGEON DUE TO THEIR SIZE, SO THAT RETRIEVAL WAS POSSIBLE. PRESUMABLY, ALL PARTS WERE FULLY RETRIEVED. THE FRAGMENTATION AND RETRIEVAL OF THE FRAGMENT PROLONGED THE PROCEDURE BY ABOUT 40 MINUTES. THE SCHEDULED SURGICAL PROCEDURE WAS COMPLETED, AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21345083 ↗MalfunctionSep 20, 2024Material Fragmentation; Material Fragmentation
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A MEDWATCH REPORT, MW5158447, REGARDING AN ISSUE WITH AN INTERNAL SHEATH RESECTOSCOPE 24FR, PART ID: 8675324, BATCH# 1562220. ACCORDING TO THE RECEIVED INFORMATION, "DURING THE PROCEDURE, THE DOCTOR IDENTIFIED THE CERAMIC TIP HAD BROKEN OFF AND WAS IN THE BLADDER. THE BROKEN ITEM WAS REMOVED AND THE OR MANAGER WAS NOTIFIED. THE DOCTOR VIEWED THE REMOVED CERAMIC TIP WITH THE ORIGINAL PART AND DETERMINED IT WAS COMPLETE. NO EVIDENCE OF ANY OTHER FOREIGN OBJECT WAS IDENTIFIED. THE BLADDER WAS IRRIGATED AND DRAINED PRIOR TO THE COMPLETION OF THE CASE." LATER INFORMATION OBTAINED, THAT THE REPORTED ISSUE CAUSED A 5-10 MINUTES DELAY DURING THE PROCEDURE WHILE THE SURGEON RETRIEVED THE BROKEN PIECE. HOWEVER, NO APPARENT HARM OCCURED IN RELATION TO THE ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20270725 ↗MalfunctionSep 20, 2024Material Fragmentation; Material Fragmentation
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A MEDWATCH REPORT, MW5158444, REGARDING AN ISSUE WITH AN INTERNAL SHEATH RESECTOSCOPE 24FR, PART ID: 8675324, BATCH# 1562242. ACCORDING TO THE RECEIVED INFORMATION, "SURGEON JUST STARTED TO PROCEED WITH THE PROCEDURE. THE STAFF IN THE ROOM NOTICED THAT THE END OF THE RESECTION SCOPE BROKE OFF INTO THE PATIENT'S BLADDER. THE PIECE OF THE SCOPE WAS REMOVED AND NO TISSUE TRAUMA WAS PRESENT TO THE PATIENT." LATER INFORMATION OBTAINED, THAT THE REPORTED ISSUE CAUSED A 5-10 MINUTES DELAY DURING THE PROCEDURE WHILE THE SURGEON RETRIEVED THE BROKEN PIECE. HOWEVER, NO APPARENT HARM OCCURED IN RELATION TO THE ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20269090 ↗InjuryAug 22, 2024Material Fragmentation; Material Fragmentation
RICHARD WOLF GMBH HAS BEEN INFORMED OF AN ISSUE REGARDING AN INTERNAL SHEATH RESECTOSCOPE 24FR, PART ID: 8675324, BATCH# 1533973. ACCORDING TO THE RECEIVED INFORMATION, DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, THE CERAMIC TIP ON THE INTERNAL SHEATH RESECTOSCOPE 24FR, PART ID: 8675324 WITH BATCH 1533973 BECAME LOOSE OR BROKE OFF INTRAOPERATIVELY. HOWEVER, THIS WAS ONLY NOTICED AFTER THE PROCEDURE. THE CLINIC WILL ARRANGE FOR THE PATIENT TO HAVE X-RAYS TAKEN AGAIN.
Patient problems: Insufficient Information
MAUDE report 20027561 ↗
Other Richard Wolf GmbH products
All Richard Wolf GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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