COBRA VISION 7356071Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04055207054864), received between Sep 11, 2018 and Mar 25, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025Break; Break

  ACCORDING TO THE INFORMATION RECEIVED, THE DEVICE BROKE WHEN THE PHYSICIAN WAS TRYING TO ADVANCE THE FLEXIBLE WORKING CHANNEL INTO THE PATIENT'S NARROW URETERAL ORIFICE. DUE TO THE NARROWED URETER, THE PRIMARY AND THE BACKUP DEVICE COULD NOT BE USED. ALSO, SINCE DOCTOR COULD NOT GET ANY ACCESS TO THE URINE OUTPUT (UO), THE SCHEDULED PROCEDURE WAS NOT COMPLETED AND NEEDED TO BE RESCHEDULED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688532 ↗
• MalfunctionOct 1, 2022Break; Material Fragmentation; Break; Material Fragmentation

  RWMIC REFERENCE COMPLAINT NO. (B)(4). THE PURPOSE OF THIS SUBMISSION IS TO UPDATE MDR WITH PATIENT INFORMATION AND ADDITIONAL PROCEDURAL INFORMATION. NEW INFORMATION ADDED BY THE USER FACILITY (SOURCE: RICHARD WOLF QUESTIONNAIRE, FORM 5206 (03); RECEIVED 10/03/2022). PURPOSE OF PROCEDURE: TREATMENT WHAT WAS THE PROCEDURE? CYSTO, URETEROSCOPY, LITHOTRIPSY WITH HOLMIUM LASER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15525696 ↗
• MalfunctionOct 1, 2022Break; Material Fragmentation; Break; Material Fragmentation

  RWMIC REFERENCE COMPLAINT (B)(4). ON SEPTEMBER 9, 2022, IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY A USER FACILITY REPRESENTATIVE REGARDING PRODUCT ID# 7356071 (B)(4). "THE PLASTIC WAS FREE-FLOATING IN THE KIDNEY. PHYSICIAN DOES BELIEVE THAT HE COLLECT ALL OF THE PIECES AND THE ENTIRE ROOM STAFF; INCLUDING MYSELF PUT OUR EYES ON IT TO AID IN HIS RETRIEVAL. AFTER I GOT THE PIECES I DID ACTUALLY PUT THEM ON THE SPOT AT THE TIP OF THE SCOPE, BEFORE THEY FELL APART THEY DID FIT." ADDITIONAL INFORMATION REPORTED BY THE USER FACILITY REPRESENTATIVE: (EMAIL, DATED SEPTEMBER 20, 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? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. NEW INFORMATION OBTAINED FROM THE USER FACILITY REPRESENTATIVE: (EMAIL, DATED SEPTEMBER 22, 2022) H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15523744 ↗
• MalfunctionJan 11, 2022Vibration; Vibration

  THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF ALL 2016-2017 COMPLAINT FILES THAT RWMIC IS COMPLETING. RECENTLY THE COMPLAINT SPECIALIST DETERMINED A RE-ASSESSMENT OF THE MDR DECISION FOR THIS COMPLAINT WAS NEEDED AND THAT FOR THIS COMPLAINT, DUE TO A DELAY IN THE PROCEDURE BEING PERFORMED THAT RESULTED IN PATIENT BEING AT RISK, AN MDR SHOULD BE FILED. PREVIOUSLY IN 2017, THE COMPLAINT SPECIALIST AT THAT TIME, DETERMINED AN MDR WAS NOT NEEDED DUE TO "NO INJURY TO PATIENT OR STAFF. BACKUP DEVICE READILY AVAILABLE FOR USE. MINIMAL DELAY, MINIMAL RISK TO PATIENT. PROCEDURE COMPLETED AS SCHEDULED." FACTS OF THE CASE AS REPORTED TO RICHARD WOLF BY THE USER FACILITY: "DISTAL TIP OF SCOPE HIGHLY SENSITIVE TO VIBRATIONS OF THE LASER, EVENT TURNING DOWN THE LASER "WATTAGE" THE IMAGE DID NOT IMPROVE. ADDITIONAL INFORMATION: 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 RIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13232269 ↗
• MalfunctionFeb 9, 2021Material Integrity Problem; Material Integrity Problem

  THE FOLLOWING WAS REPORTED TO RW (B)(4): THE 7356071 SENSOR-URETEROROSCOPE 9.9CH NL 680MM GOT STUCK IN THE ACCESS SLEEVE WHEN IT WAS FIRST USED. THE PROBLEM WAS THAT THE SLEEVE WAS LOOSE AT THE DISTAL END AND APPARENTLY TOO LONG TO BE ROLLED UP . THIS POSED QUITE A PROBLEM DURING THE PROCEDURE. FURTHER DETAILED INFORMATION WAS NOT PROVIDED BY THE USER, DESPITE THREE REQUESTS FROM RICHARD WOLF.

  Patient problems: Insufficient Information

  MAUDE report 11302910 ↗
• MalfunctionAug 29, 2019Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION. ACCORDING TO THE INVESTIGATION COMPLETED BY RICHARD WOLF: PRODUCT APPEARANCE: USED. COMPLAINT CONDITION VERIFIED: YES. REPEAT REPAIR: NO. MET SPECIFICATIONS: NO (SEE PHYSICAL FINDINGS). TEST METHOD: OTHER (SEE EQUIPMENT USED). EQUIPMENT USED: CONTROLLER TYPE 5225108, LEAK TESTER. PROBABLE ROOT CAUSE: USER ERROR/MISUSE. COMPLAINT VALID: NO, HANDLING ERROR DURING LASER APPLICATION. ACTION REQUIRED: ROUTINE MAINTENANCE. OTHER: REPAIR EXCHANGE RECOMMENDED. AS WRITTIN IN INSTRUCTION MANUAL GA-D370 CHAPTER 7.6 "DO NO WORK OUTSIDE THE SCOPES FIELD OF VIEW!". PHYSICAL FINDINGS: THE DEFLECTION, THE LASER CHANNEL AND THE DISTAL TUBE OF THE INSTRUMENT HAVE BEEN DAMAGED BY LASER ENERGY. CONCLUSION: THE CAUSE OF THE DAMAGES IS DUE TO A HANDLING ERROR DURING LASER APPLICATION. USER DIDN'T FOLLOW INSTRUCTION MANUAL GA-D370 CHAPTER 7.6. ADDITIONAL INFORMATION FROM THE MANUFACTURER: "THE DAMAGE DESCRIBED HERE IS AS FOLLOWS ARE CAUSED BY INCORRECT HANDLING DURING LASER APPLICATION CAUSED BY THE FACT THAT A LASER FIBER IS NOT PRESENT IN THE ENDOSCOPIC VISUAL RANGE HAS BEEN ACTIVATED, IN THE GA-D375 CHAPTER 7.5 THE US

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8947691 ↗
• MalfunctionAug 23, 2019Blocked Connection; Mechanical Jam; Blocked Connection; Mechanical Jam

  ON JULY 24, 2019, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): DURING A PROCEDURE, "200 TRAC TIP" FIBER WAS ADVANCED THROUGH BOTH WORKING CHANNELS AND IT GOT HUNG UP AND WOULD NOT ADVANCE ALL THE WAY. 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? UNKNOWN. 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? GENERAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 8927182 ↗
• MalfunctionAug 19, 2019Connection Problem; Mechanical Jam; Connection Problem; Mechanical Jam

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION. ACCORDING TO THE INVESTIGATION COMPLETED BY RICHARD WOLF: PRODUCT APPEARANCE: OTHER: NO PROBLEM FOUND. COMPLAINT CONDITION VERIFIED: NO, NO PROBLEM FOUND. REPEAT REPAIR: NO, NO PROBLEM FOUND. MET SPECIFICATIONS: YES. TEST METHOD: VISUAL, FUNCTIONAL. EQUIPMENT USED: LEAK RESTER, CAMERA SETUP. PROBABLE ROOT CAUSE: OTHER, NO PROBLEM FOUND. COMPLAINT VALID: NO PROBLEM FOUND. ACTION REQUIRED: ROUTINE MAINTENANCE. PHYSICAL FINDINGS: NO PROBLEM FOUND. CONCLUSION: SCOPE PASS ALL TESTS. THE USER IS INFORMED IN THE RELATED IFU GA-D 370 / USA / 2015-04 V3.0 / ECO 2015-0069 ABOUT THE CAUTIONS AND FUNCTIONAL CHECKS OF THE DEVICE: CAUTION! TO AVOID DAMAGE TO THE LASER FIBER CHANNEL (17), - DO NOT USE FORCE TO INSERT OR WITHDRAW THE LASER FIBER (X) INTO/FROM THE LASER FIBER CHANNEL (18). - INSERT AND WITHDRAW THE LASER FIBER (X) THROUGH THE LASER FIBER CHANNEL ONLY IF THE INSTRUMENT SHEATH (5) IS STRAIGHT AND THE INSTRUMENT TIP (4) IS STRAIGHT (17). ANGLE (DEFLECT) THE URS ONLY WHEN THE LASER FIBER (X) IS CORRECTLY POSITIONED. CAUTION! TO AVOID DAMAGE TO THE WORKING CHANNEL (1) AND THE BIOPSY VALVE SET (10), - DO

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 8908088 ↗
• MalfunctionSep 11, 2018No Display/Image; Display or Visual Feedback Problem; Display or Visual Feedback Problem

  RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION, HEREINAFTER REFERRED TO AS RWMIC WAS NOTIFIED OF AN EVENT THAT OCCURRED AT THE HOSPITAL, ON AN UNSPECIFIED DATE, DURING A PATIENT PROCEDURE. THE PICTURE ALLEGEDLY FROZE UP WHILE SCOPE WAS IN THE URETER. A BACK UP DEVICE WAS AVAILABLE AND THE PROCEDURE WAS COMPLETED. THERE WAS A DELAY IN THERAPY THAT PUT THE PATIENT AT RISK BUT THERE WAS NO ADVERSE OUTCOME REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7866793 ↗