SHARK 8675324Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04055207019658), received between Jun 17, 2019 and Sep 16, 2026 — classified as 8 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (17 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 25 most recent of 27 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 12, 2023Material Fragmentation; Material Fragmentation

  THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH (RWGMBH) OF AN ISSUE REGARDING AN INTERNAL SHEATH RESECTOSCOPE 24FR, PART ID: 8675324, LOT # 1304359. ACCORDING TO THE RECEIVED INFORMATION, "AT THE BEGINNING OF THE HOLMIUM LASER ENUCLEATION OF THE PROSTATE, THE SURGEON NOTICED DURING CYSTOSCOPY THAT THE CERAMIC TIP OF THE INNER SHAFT WAS FLOATING IN THE BLADDER. CONSIDERATION WAS GIVEN TO HOW THIS TIP COULD BE REMOVED FROM THE BLADDER WITHOUT DAMAGING THE URETHRA. THE CERAMIC TIP WAS GRASPED AT THE BLUNTER END AND EXTRACTED FROM THE BLADDER. THE PATIENT WAS NOT HARMED."

  Patient problems: Insufficient Information

  MAUDE report 18312813 ↗
• InjuryJul 26, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  ACCORDING TO THE RECEIVED INFORMATION FROM THE CUSTOMER, THERE WAS A "BREAKAGE OF THE BAKELITE INNER JACKET AT THE JUNCTION OF THE INSTRUMENT (THE METAL TUBE SEPARATED FROM THE CIRCULAR LOCK WHEN CHANGING THE INSTRUMENTATION AFTER ENUCLEATION TO SWITCH TO MORCELLATION. APRIORI NO FORCEFUL GESTURE AT THE INTRODUCTION OF THE CAMERA." THE DETACHED PART OF THE INNER SHEATH (METAL TUBE) FELL INTO THE BLADDER AND PERFORATED THE BOTTOM OF THE BLADDER INTO THE PATIENT'S PERITONEUM. LT WAS NECESSARY TO COMPLETE THE OPERATION BY LAPAROTOMY FOR ABDOMINAL EXPLORATION AND SUTURE THE BLADDER. ADDITIONALLY, THERE WAS NO REPORTED DIGESTIVE PERFORATION. THE LAPAROTOMY TOOK LONGER THAN EXPECTED AND AS A CONSEQUENCE, THERE WAS A REPORTED DELAY OF BETWEEN 15 AND 30 MINUTES. PATIENT MEDICAL TREATMENT REQUIRED AN EXTENSION OF STAY AT THE HOSPITAL FOR 6 DAYS. THIS CASE WAS REPORTED BY THE CUSTOMER TO THE FRENCH NATIONAL AGENCY FOR THE SAFETY OF MEDICINES AND HEALTH PRODUCTS (ANSM).

  Patient problems: Peritoneal Laceration(s)

  MAUDE report 17396928 ↗
• InjuryJun 30, 2023Material Separation; Material Separation

  A USER FACILITY HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A INTERNAL SHEATH RESECTOSCOPE 24FR, PART ID: 8675324, SERIAL # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, "DURING SURGERY, SUDDEN SHEARING OFF OF AN APPROX. 1 CM LONG CYLINDRICAL FOREIGN BODY CORRESPONDING TO THE INSIDE OF THE RESECTOSCOPE SHAFT. DUE TO INCORRECT USE OF THE SNARE RESECTION, THIS DEFECT WAS ONLY DETECTED OPTICALLY AFTERWARDS. THE FOREIGN BODY WAS THEN REMOVED ENDOSCOPICALLY WITH GRASPING FORCEPS. BY CHANGING THE SURGICAL TECHNIQUE, THE PATIENT COULD BE TREATED WITH A PROLONGED SURGICAL TIME AS INITIALLY."

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17240803 ↗
• MalfunctionJan 24, 2023Break; Material Separation; Break; Material Separation

  RWGMBH REFERENCE COMPLAINT NO. (B)(4). THE PURPOSE OF THIS SUBMISSION IS TO PROVIDE A CORRECTION ON G3: DATE RECEIVED BY MANUFACTURER. SEE H10 FOR FURTHER EXPLANATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16235640 ↗
• InjuryOct 12, 2022Material Fragmentation; Material Fragmentation

  RWGMBH REFERENCE COMPLAINT NO. (B)(4). RICHARD WOLF GMBH IN KNITTLINGEN (MANUFACTURER) WAS INFORMED ABOUT A USER NOTIFICATION TO THE ITALIAN COMPETENT AUTHORITY VIA DISTRIBUTOR. DESCRIPTION OF INCIDENT/CLAIM: DURING A THULEP PROCEDURE, A COMPONENT OF THE BIPOLAR RESECTOSCOPE WAS APPARENTLY LOST IN THE PATIENT, BUT THIS WAS ONLY NOTICED AFTER THE PROCEDURE WAS COMPLETED. THE PATIENT THEREFORE HAD TO UNDERGO ANOTHER MINIMALLY INVASIVE SURGERY 3 DAYS LATER TO HAVE THE FOREIGN BODY REMOVED. THIS CASE WAS REPORTED BY THE USER TO THE ITALIAN AUTHORITIES. RWGMBH MDR AWARENESS DATE: 23-SEPT-2022

  Patient problems: Foreign Body In Patient

  MAUDE report 15587820 ↗
• InjuryJul 22, 2022Break; Material Fragmentation; Break; Material Fragmentation

  RWMIC REFERENCE COMPLAINT NO. (B)(4). IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) THAT "TIP BROKE OFF DURING A PROCEDURE. DELAY TIME WAS 15 MINUTES." ADDITIONAL INFORMATION REPORTED BY THE INITIAL REPORTER: 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. ADDITIONAL DETAILS ABOUT THE ADVERSE EVENT; (B)(6) 2022. WHAT WAS THE SCHEDULED PROCEDURE BEING PERFORMED WHEN THE TIP BROKE? TRANSURETHRAL INCISION OF THE PROSTATE (TUIP). DID THE TIP BREAK INSIDE OR OUTSIDE OF THE PATIENT? YES. WHAT ACTIONS WERE BEING DONE DURING THE DELAY? REMOVE THE TIP OF THE SHEATH FROM THE PATIENT. DID THE PATIENT REQUIRE ANY ADDITIONAL TREATMENT DURING THE DELAY OR WILL REQUIRE ANOTHER PROCEDURE AS THE RESULT OF THE DELAY? NO. WHAT WAS THE PATIENT'S OU

  Patient problems: Foreign Body In Patient

  MAUDE report 15084792 ↗
• MalfunctionJul 22, 2022Break; Material Fragmentation; Break; Material Fragmentation

  RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) REFERENCE (B)(4). IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) THAT "TIP BROKE OFF DURING A PROCEDURE. DELAY TIME WAS 15 MINUTES." ADDITIONAL INFORMATION REPORTED BY THE INITIAL REPORTER: 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. ADDITIONAL DETAILS ABOUT THE ADVERSE EVENT; (B)(6) 2022. (1) WHAT WAS THE SCHEDULED PROCEDURE BEING PERFORMED WHEN THE TIP BROKE? TRANSURETHRAL INCISION OF THE PROSTATE (TUIP). (2) DID THE TIP BREAK INSIDE OR OUTSIDE OF THE PATIENT? YES. (3) WHAT ACTIONS WERE BEING DONE DURING THE DELAY? REMOVE THE TIP OF THE SHEATH FROM THE PATIENT. (4) DID THE PATIENT REQUIRE ANY ADDITIONAL TREATMENT DURING THE DELAY OR WILL REQUIRE ANOTHER PROCEDURE AS THE RESULT

  Patient problems: Foreign Body In Patient

  MAUDE report 15084780 ↗
• MalfunctionJul 6, 2022Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  RICHARD WOLF GMBH COMPLAINT REFERENCE (B)(4). PLANNED SURGERY: VIDEO MINIMALLY INVASIVE RTU BIPOLAR PROCEDURE. DURING A VIDEO MINIMALLY INVASIVE RTU BIPOLAR PROCEDURE, THE SHARK RESECTOSCOPE SHEATH 8675324 BROKE THE CERAMIC TIP, WHICH WAS LOST IN THE PATIENT'S ABDOMINAL CAVITY. IT WAS NECESSARY TO PERFORM AN OPEN AND MORE COMPLEX PROCEDURE TO REMOVE THE LOOSE PART. RWGMBH AWARENESS DATE: 23-JUN-2022.

  Patient problems: Insufficient Information

  MAUDE report 14932666 ↗
• MalfunctionJun 23, 2022Material Fragmentation; Material Fragmentation

  RICHARD WOLF GMBH COMPLAINT REFERENCE (B)(4). PLANNED SURGERY: HOLEP. IMMEDIATELY AFTER INSERTION OF THE INSTRUMENT INTO THE BLADDER, A PART OF THE CERAMIC TIP BROKE OFF. AFTER ABOUT 30 MINUTES, THE REST OF THE CERAMIC TIP BROKE OFF. DUE TO THE RETRIEVAL AND REPLACEMENT OF THE RESECTOSCOPE SHAFT, THE SURGERY TIME WAS EXTENDED BY APPROXIMATELY 45 MINUTES. THE PATIENT SUFFERED AN INJURY TO THE URETHRA AND BLADDER MUCOSA. THERE WAS PROLONGED POSTOPERATIVE BLEEDING. RWGMBH AWARENESS DATE, 20-JUN-2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 14791629 ↗
• MalfunctionMay 4, 2022Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  RICHARD WOLF MEDICAL INSTRUMENTS RECEIVED A CALL ON (B)(6) 2022 AT 11:15 AM FROM THE WIFE (CC) OF A PATIENT (WC) UNDERGOING A PROCEDURE. HERE ARE THE NOTES FROM THAT CALL: DR. (B)(6) PERFORMED A SURGICAL PROCEDURE ON (B)(6) 2022 TO ADDRESS WC'S BLADDER PROBLEM. A RICHARD WOLF RESECTOSCOPE WAS BEING USED TO BIOPSY TISSUE THAT WAS SUSPECT TO BE CANCEROUS. THE PATIENT WAS INFORMED THAT THE TIP HAD BROKEN OFF DURING THE PROCEDURE AND IT TOOK THE SURGEON ~ 1 HOUR TO SUCCESSFULLY RETRIEVE THE PIECE. CC DID NOT KNOW THE SPECIFIC MODEL ONLY THAT IT WAS MADE BY RICHARD WOLF. THE PROCEDURE WAS UNSUCCESSFUL TO RETRIEVE A VIABLE BIOPSY. THE PATIENT REPORTEDLY BLED FOR 3 WEEKS POST-SURGERY. 2ND PROCEDURE WAS PERFORMED ON (B)(6) 2022 BY THE SAME SURGEON. SPECIAL INSTRUMENTATION THE SURGEON HAD USED IN ANOTHER FACILITY WAS USED. CC DID NOT KNOW WHAT INSTRUMENTATION WAS USED NOR THE MANUFACTURER. PROCEDURE WAS SUCCESSFUL. PATIENT IS RECOVERING AND DOING WELL. ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL: 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? UNKNOW

  Patient problems: Insufficient Information

  MAUDE report 14282160 ↗
• InjuryMay 4, 2022Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  RICHARD WOLF MEDICAL INSTRUMENTS RECEIVED A CALL ON (B)(6) 2022 AT 11:15 AM FROM THE WIFE (B)(6) OF A PATIENT (B)(6) UNDERGOING A PROCEDURE. HERE ARE THE NOTES FROM THAT CALL: DR. (B)(6) PERFORMED A SURGICAL PROCEDURE ON (B)(6) 2022 TO ADDRESS (B)(6) BLADDER PROBLEM. A RICHARD WOLF RESECTOSCOPE WAS BEING USED TO BIOPSY TISSUE THAT WAS SUSPECT TO BE CANCEROUS. THE PATIENT WAS INFORMED THAT THE TIP HAD BROKEN OFF DURING THE PROCEDURE AND IT TOOK THE SURGEON ~ 1 HOUR TO SUCCESSFULLY RETRIEVE THE PIECE. (B)(6) DID NOT KNOW THE SPECIFIC MODEL ONLY THAT IT WAS MADE BY RICHARD WOLF. THE PROCEDURE WAS UNSUCCESSFUL TO RETRIEVE A VIABLE BIOPSY. THE PATIENT REPORTEDLY BLED FOR 3 WEEKS POST-SURGERY. 2ND PROCEDURE WAS PERFORMED ON (B)(6) 2022 BY THE SAME SURGEON. SPECIAL INSTRUMENTATION THE SURGEON HAD USED IN ANOTHER FACILITY WAS USED. (B)(6) DID NOT KNOW WHAT INSTRUMENTATION WAS USED NOR THE MANUFACTURER. PROCEDURE WAS SUCCESSFUL. PATIENT IS RECOVERING AND DOING WELL. ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL: 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

  Patient problems: Insufficient Information

  MAUDE report 14274135 ↗
• MalfunctionJul 14, 2021Material Fragmentation; Material Fragmentation

  AFTER AN HOUR TURP BIPOLAR SURGERY, THE CASE WAS ALMOST FINISHED. WHEN THEY WERE GOING TO USE ELICK TO REMOVE THE RESIDUE OF PROSTATE, THEY FOUND A BLACK METAL CRACK INSIDE THE PROSTATE. THEY REMOVED THE INNER SHEATH AND CHECKED, THEY FOUND THE WHOLE TIP OF THE INNER SHEATH WAS GONE. THEY EXAMINED INSIDE THE BLADDER, THE TIP HAS BEEN BROKEN INTO 2 PIECES, THEY USED A FORCEPS TO GRASP AND TRY TO REMOVE FROM PATIENT, HOWEVER, AS THE URETHRA OF PATIENT WAS VERY NARROW, THE GRASPER DID NOT HAVE ENOUGH FORCE TO REMOVE IT. FINALLY, IT TOOK ALMOST 1.5 HOURS TO REMOVE 2 PIECES OF METAL FROM PATIENT AND IT SHOULD BE A COMPLETE BROKEN PARTS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166582 ↗