Cystotome G30550Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00827002305502), received between Dec 20, 2016 and Oct 2, 2019 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  NEEDLE KNIFE CANNOT BE REMOVED. PRODUCTS WILL BE AVAILABLE FOR EXAMINATION. AS PER COMPLAINT FORM: "WHEN REMOVING THE NEEDLE KNIFE FROM THE DEVICE, THE NEEDLE WIRE GOT STUCK WITH THE WELDING POINT BETWEEN NEEDLE KNIFE AND WIRE AT THE LÜER-CONNECTION." FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿INNER CATHETER STUCK/DIFFICULT TO RETRACT'.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9144075 ↗
• MalfunctionOct 2, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  NEEDLE KNIFE CANNOT BE REMOVED. PRODUCTS WILL BE AVAILABLE FOR EXAMINATION AS PER COMPLAINT FORM: "WHEN REMOVING THE NEEDLE KNIFE FROM THE DEVICE, THE NEEDLE WIRE GOT STUCK WITH THE WELDING POINT BETWEEN NEEDLE KNIFE AND WIRE AT THE LÜER-CONNECTION." FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿INNER CATHETER STUCK/DIFFICULT TO RETRACT'.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9144035 ↗
• MalfunctionAug 8, 2019Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation; Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation

  AFTER USING THE NEEDLE KNIFE THE NURSE WANTS TO REMOVE THE NEEDLE KNIFE FROM THE DEVICE. THIS WAS NEARLY IMPOSSIBLE. STARTING TO REMOVE SHE FELT A STRONGER FRICTION THAN USUAL. AND AT THE END (HANDLE) THERE WAS A STRONG RESISTANCE, WHICH RESULTED IN DESTRUCTION OF THE DEVICE, THE PROCEDURE COULD BE COMPLETED WITH A SECOND DEVICE FROM THE SAME LOT WITHOUT PROBLEMS. THIS INSTRUMENT WAS DISPOSED OF. A DAY LATER THE SAME HAPPENED WITH THE DEVICE IN THIS COMPLAINT. TO AVOID PROBLEMS, THE NURSE TESTED THE REST OF HER DEVICES AND FOUND TWO MORE WITH THE SAME PROBLEM. THE CUSTOMER IS VERY EXPERIENCED IN USING THIS PRODUCT AND STATED THIS HAS NEVER HAPPENED BEFORE. THERE MUST BE SOME PROBLEM IN THE HANDLE, SHE SAID. ALL DEVICES WERE FROM THE SAME LOT. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿INNER CATHETER STUCK/DIFFICULT TO RETRACT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8873514 ↗
• MalfunctionAug 8, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  AFTER USING THE NEEDLE KNIFE THE NURSE WANTS TO REMOVE THE NEEDLE KNIFE FROM THE DEVICE. THIS WAS NEARLY IMPOSSIBLE. STARTING TO REMOVE SHE FELT A STRONGER FRICTION THAN USUAL. AND AT THE END (HANDLE) THERE WAS A STRONG RESISTANCE, WHICH RESULTED IN DESTRUCTION OF THE DEVICE, THE PROCEDURE COULD BE COMPLETED WITH A SECOND DEVICE FROM THE SAME LOT WITHOUT PROBLEMS. THIS INSTRUMENT WAS DISPOSED OF.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8873495 ↗
• MalfunctionJun 14, 2019Off-Label Use; Off-Label Use

  THE NEEDLE KNIFE OF THE CYSTOTOME WAS NOT USED, ONLY THE OUTER 10FR DIATHERMIC RING WAS USED FOR DILATION. THE PURE CUTTING CURRENT WITHIN THE RANGE OF 80-120 WATTS WAS USED TO ACTIVATE THE PROXIMAL ELECTRODE OF THE DIATHERMIC RING. HOWEVER, IT ONLY RESULTED WITH THE TIP OF THE DIATHERMIC RING BEING BURNT WITHOUT ANY SIGN OF DILATION ON THE PSEUDOCYST. A SECOND CYSTOTOME WAS USED, WITH THE SAME CURRENT SETTINGS, HOWEVER IT ALSO HAD THE SAME RESULT OF NOT BEING ABLE TO DILATE THE OPENING. THE THIRD CYSTOTOME OF A DIFFERENT LOT NUMBER WAS USED, AND THERE WAS NO PROBLEM WITH DILATING THE CYST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8699529 ↗
• MalfunctionMar 15, 2019Failure to Advance; Failure to Advance

  CYSTOTOME CREATES A FISTULA BETWEEN THE STOMACH AND THE PANCREATIC DUCT. THIS DEVICE COULD NOT BE SET UP ON THE GUIDE BECAUSE OF A SIGNIFICANT FRICTION. FURTHER ABNORMAL DIFFICULTY FOR REMOVAL OF THE INTERNAL STYLET AND REMOVAL OF THE GUIDE IN PLACE. RENEWAL WITH A SECOND DM IDENTICAL GUIDE) UNDER THE SAME CONDITIONS WENT SMOOTHLY. PATIENT INJURY TO BE CONFIRMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8423873 ↗
• MalfunctionAug 8, 2018Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS "THE DOCTOR USED A 19G COOK ECHOTIP ULTRA NEEDLE TO PUNCTURE THE CYST. HE THEN PROCEEDED TO PLACE A 450CM JAGWIRE. AN EXCHANGE WAS PERFORMED LEAVING THE WIRE IN PLACE. HE THEN PROCEEDED TO REMOVE THE ZIMMON NEEDLE KNIFE AND PLASTIC 5F CATHETER FROM THE CYSTOTOME. THE 10F DIATHERMIC RING WAS THEN ADVANCED OVER THE PRE-POSITIONED WIRE. HE THEN POSITIONED THE ENDOTHERMIC USING FLUOROSCOPY. THIS WAS ALSO CONFIRMED WHEN RESISTANCE WAS FELT WHILE PUSHING THE 10F CATHETER. THE ERBY MACHINE WAS ET TO ¿ENDOCUT¿ 100 WATTS. WHILE PUSHING ON THE PEDDLE, THE DOCTOR COMMENTED THAT NO CURRENT WAS DELIVERED TO THE DIATHERMIC RING. HE CONTINUED FOR ABOUT A MINUTE OR SO. VISUALLY, NO BURNING WAS SEEN EITHER. HE THEN REMOVED THE CYSTOTOME AND DECIDED TO DILATE THE OPENING WITH A 12MM BALLOON. HE THEN COMPLETED THE CASE WITH PLACING TWO WIRES AND 2 ZIMMON 7F,7CM DOUBLE PIGTAIL STENTS. THE ERBY MACHINE WAS CONFIRMED TO BE WORKING AS SUBSEQUENT ERCPS WERE OK."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7761065 ↗
• MalfunctionMar 15, 2018Break; Break

  THE WHITE TIP FELL OF FROM THE REST OF THE CYSTECTOMY DURING THE PROCEDURE. "AS PER COMPLAINT FORM": CUSTOMER OPENED THE PACKAGE AND TOOK THE PRODUCT ALL SEEMED OK. THEY STARTED EXAMINATION BY EUS PUNCTURE WITH 19 NEEDLE FROM BOSTON THEY PUT GUIDE WIRE INSIDE THE CYST. THEY REMOVED THE PUNCTURE NEEDLE AND KEPT THE GUIDE WIRE INSIDE THE CYST. THEY REMOVED THE NEEDLE FROM CST-10 AND SLIDE CST-10 ON 0.25 VISIGLIDE GUIDE WIRE. THEN THEY SLIDE THE BLACK 10 FR CATHETER ON THE CLEAR CATHETER AND PERFORMED A HOLE INTO THE GASTRIC MUCOSA. THEY STARTED TO "REMOVE" THE CLEAR CATHETER ON GUIDE WIRE ALL WAS GOOD BUT ONE MOMENT THE CLEAR CATHETER STAYED BLOCK THEY PULLED ON AND THE WHITE RIGID PART DISCONNECTED FROM THE CLEAR CATHETER. THEY SUCCEED TO REMOVE THE CLEAR CATHETER AND THEY FINISHED THE EXAMINATION WITHOUT OTHER PB. THEY PUT 2 CBSO-7-5 WITHOUT PROBLEM. PATIENT WAS OK. THE JUNCTION BETWEEN WHITE PART AND CLEAR CATHETER SHOULD BE IMPROVED SOME COLLEAGUES TOLD ME THAT THEY ALREADY HAD THIS PROBLEM IN THE PAST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7341610 ↗
• MalfunctionJan 25, 2018Failure to Advance; Failure to Advance

  NEEDLE WAS NOT COMING OUT DURING PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7217949 ↗
• MalfunctionOct 20, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  THIS FOLLOW UP MDR IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. THE USER OPENED THE PACKAGE AND FOUND THE TIP OF THE DEVICE WAS CROOKED, SO THE USER CHANGE ANOTHER NEW DEVICE TO CONTINUE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6964827 ↗
• MalfunctionSep 7, 2017Component Incompatible; Component or Accessory Incompatibility; Component Incompatible; Component or Accessory Incompatibility

  ENDOFLEX ADAPTER DID NOT FIT THE CONNECTION OF THE CYSTOTOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6848259 ↗
• MalfunctionAug 28, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE PACKAGING WAS TORN AND THE PRODUCT IS DESTERILISED.

  Patient problems: No Patient Involvement

  MAUDE report 6824408 ↗
• MalfunctionAug 4, 2017Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  THIS FOLLOW UP CANCELLATION MDR IS BEING SUBMITTED THE CANCEL THE INITIAL REPORT SUBMITTED. THE RISK HAS BEEN EVALUATED FOLLOWING COMPLETION OF THE INVESTIGATION AND THE RISK HAS BEEN DETERMINED TO BE LOW. AN INITIAL MALFUNCTION REPORT WAS SUBMITTED TO ERR ON THE SIDE OF CAUTION PENDING INVESTIGATION COMPLETION. NO MALFUNCTION PRECEDENCE EXISTS FOR THIS DEVICE OR ISSUE. AS REPORTED TO CUSTOMER RELATIONS: "THE NEEDLE KNIFE WOULD NOT COME OUT OF THE DISTAL TIP. DOC HAD TO REMOVE THE DEVICE AND MANUALLY PULL OUT THE NEEDLE KNIFE, REINSERTING THE CYSTOTOME DOWN THE SCOPE WITH THE NEEDLE KNIFE EXPOSED, WHICH IS AGAINST IFU THIS HAPPENED WITH THE SECOND DEVICE AS WELL."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6766988 ↗
• MalfunctionMar 14, 2017Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DEFECT BEFORE USE IN PATIENT "AS PER COMPLAINT FORM": PRODUCT BROKE BEFORE USE IN THE BAG... PICTURE PROVIDED INDICATED WHITE HANDLE WAS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6402476 ↗
• MalfunctionMar 10, 2017Retraction Problem; Retraction Problem

  IMPOSSIBLE TO RETRACT INNER CATHETER AFTER BURNING ¿ BUT POSSIBLE TO PLACE A STENT AFTERWARDS. AFTER BURNING THROUGH THE CYST WITH THE CST-1 KNIFE THE USER WANTED TO RETRACT THE INNER CATHETER TO PUT SUCTION TO THE OUTER CATHETER TO SEE IF THE CYST CONTAINS BLOOD OR PUS - AND THE INNER CATHETER WAS STUCK AT THE OUTER CATHETER - WITH A LOT OF FORCE IT WAS NOT POSSIBLE TO RETRACT THE INNER CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6394411 ↗
• MalfunctionDec 20, 2016Retraction Problem; Retraction Problem

  THIS IS A FOLLOW UP REPORT FOLLOWING THE COMPLETION OF THE INVESTIGATION. IT WAS REPORTED THAT THE CUSTOMER HAS HAD HUGE DIFFICULTIES WITH CYSTOTOME. HE SAID THE MAIN PROBLEM IS THAT HE CANNOT SEPARATE CATHETER WHEN PLACING THE STENT IN PATIENT. USING THE CYSTOTOME: PLACING THE INNER CATCH FIRST AND BURNING SMALL HOLE THEN PRESSING THE OUTER CATHETER 10 FR OVER THE INNER AND BURNING 2ND TIME - THEN USUALLY YOU RETRACT THE INNER-CATCH BECAUSE YOU WANT TO PLACE A STENT IN THE HOLE TO DRAIN THE CYST - IF YOU DO NOT PLACE A STENT THE PATIENT HAS A HOLE THAT CLOTS AND WILL NOT GET DRAIN FOR THE BACTERIAL FLUID. IN THESE CASES(ALL 3) IT WAS NOT POSSIBLE TO RETRACT THE INNER-CATCH - IT WAS STUCK - AND THEY HAD TO PULL EVERY TOOL OUT AND FINISH ALL PROCEDURES AT OR. IT WAS CONFIRMED THAT THERE WAS A DELAY IN THE PROCEDURE AS A RESULT OF THE DEVICE FAILURE. THE PATIENT REQUIRED SURGERY IN THE OR TO COMPLETE THE PROCEDURE WITH ANOTHER DEVICE. THE CUSTOMER HAS USED THE CYSTOTOME FOR 15 YEARS AND ARE QUITE SKILLED USING IT. THIS IS THE 3RD TIME IN 2 WEEKS. REFERENCE ALSO RELATED REPORT# 3001845648-2016-00371 AND REPORT# 3001845648-2016-00372.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6188438 ↗
• MalfunctionDec 20, 2016Retraction Problem; Retraction Problem

  THIS IS A FOLLOW UP REPORT FOLLOWING THE COMPLETION OF THE INVESTIGATION. IT WAS REPORTED THAT THE CUSTOMER HAS HAD HUGE DIFFICULTIES WITH CYSTOTOME. HE SAID THE MAIN PROBLEM IS THAT HE CANNOT SEPARATE CATHETER WHEN PLACING THE STENT IN PATIENT. USING THE CYSTOTOME: PLACING THE INNER CATCH FIRST AND BURNING SMALL HOLE(1) THEN PRESSING THE OUTER CATHETER 10 FR OVER THE INNER AND BURNING 2ND TIME(2) - THEN USUALLY YOU RETRACT THE INNER-CATCH BECAUSE YOU WANT TO PLACE A STENT IN THE HOLE TO DRAIN THE CYST - IF YOU DO NOT PLACE A STENT, THE PATIENT HAS A HOLE THAT CLOTS AND WILL NOT GET DRAIN FOR THE BACTERIAL FLUID. IN THESE CASES(ALL 3) IT WAS NOT POSSIBLE TO RETRACT THE INNER-CATCH - IT WAS STUCK - AND THEY HAD TO PULL EVERY TOOL OUT AND FINISH ALL PROCEDURES AT OR. IT WAS CONFIRMED THAT THERE WAS A DELAY IN THE PROCEDURE AS A RESULT OF THE DEVICE FAILURE. THE PATIENT REQUIRED SURGERY IN THE OR TO COMPLETE THE PROCEDURE WITH ANOTHER DEVICE. THE CUSTOMER HAS USED THE CYSTOTOME FOR 15 YEARS AND ARE QUITE SKILLED USING IT. THIS IS THE 3RD TIME IN 2 WEEKS. REFERENCE ALSO RELATED REPORT# 3001845648-2016-00371 AND REPORT# 3001845648-2016-00373.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6188418 ↗
• MalfunctionDec 20, 2016Retraction Problem; Retraction Problem

  A FOLLOW-UP MDR IS BEING SUBMITTED TO INCLUDE THE DEVICE EVALUATION DETAILS AND INVESTIGATION CONCLUSIONS. INITIAL COMPLAINT DETAILS: IT WAS REPORTED THAT THE CUSTOMER HAS HAD HUGE DIFFICULTIES WITH CYSTOTOME. HE SAID THE MAIN PROBLEM IS THAT HE CANNOT SEPARATE CATHETER WHEN PLACING THE STENT IN PATIENT. USING THE CYSTOTOME: PLACING THE INNER CATCH FIRST AND BURNING SMALL HOLE THEN PRESSING THE OUTER CATHETER 10 FR OVER THE INNER AND BURNING 2ND TIME - THEN USUALLY YOU RETRACT THE INNER-CATCH BECAUSE YOU WANT TO PLACE A STENT IN THE HOLE TO DRAIN THE CYST - IF YOU DO NOT PLACE A STENT THE PATIENT HAS A HOLE THAT CLOTS AND WILL NOT GET DRAIN FOR THE BACTERIAL FLUID. IN THESE CASES (ALL 3) IT WAS NOT POSSIBLE TO RETRACT THE INNER-CATCH - IT WAS STUCK - AND THEY HAD TO PULL EVERY TOOL OUT AND FINISH ALL PROCEDURES AT OPERATING ROOM (OR). IT WAS CONFIRMED THAT THERE WAS A DELAY IN THE PROCEDURE AS A RESULT OF THE DEVICE FAILURE. THE PATIENT REQUIRED SURGERY IN THE OR TO COMPLETE THE PROCEDURE WITH A DIFFERENT DEVICE. THE CUSTOMER HAS USED THE CYSTOTOME FOR 15 YEARS AND ARE QUITE SKILLED USING IT. THIS IS THE 3RD TIME IN 2 WEEKS. REFERENCE ALSO RELATED REPORT# 3001845648-2016-00372 AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6188416 ↗