Zimmon G21396Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00827002213968), received between Aug 15, 2017 and Oct 27, 2025 — classified as 2 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (31 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 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON .01-DEC-2025. 08OCT2025 ADDITIONAL INFORMATION WAS OBTAINED. 1. WHAT WAS THE SIZE OF THE WIREGUIDE USED IN THE PREPARATION STAGES? 0.035 OR 0.025 2. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. ON A SHELF IN A ROOM THAT IS NOT EXPOSED TO LIGHT. 3. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES 4. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? NI. 5. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? NI. 6. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE? NO. 7. WHAT IS THE ENDOSCOPE MANUFACTURER, THE MODEL NUMBER AND WORKING CHANNEL SIZE THAT WAS USED FOR THE PROCEDURE? OLYMPUS/JF260V.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391344 ↗
• MalfunctionSep 30, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13-NOV-2025. ADDITIONAL INFORMATION RECEIVED - 01 OCT 2025 1. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. STORED ON A SHELF IN THE ENDOSCOPY ROOM AT ROOM TEMPERATURE. 2. WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? OLYMPUS, VISIGLIDE2, OD: 0.63MM. 3. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. 4. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? NO. 5. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? NO. 6. WERE PREVIOUS PROCEDURES I.E., SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? NI. 7. DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? NI. 8. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE? NO. 9. WHAT IS THE ENDOSCOPE MANUFACTURER, THE MODEL NUMBER AND WORKING CHANNEL SIZE THAT WAS USED FOR THE PROCEDURE? NI. 10. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? NI 11. WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23178713 ↗
• MalfunctionFeb 4, 2020Difficult to Advance; Difficult to Advance

  AFTER OPENING THE PACKAGE AND STRAIGHTENING THE STENT WITH A STRAIGHTER, THE PHYSICIAN ATTEMPTED TO INSERT A WIRE GUIDE (0.025 INCH VISIGLIDE2/OLYMPUS) INTO THE STENT, BUT THE WIRE GUIDE COULD NOT BE ADVANCED IN THE STENT. THEREFORE, ANOTHER ZEBD-7-7 WAS USED INSTEAD TO CONTINUE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9664087 ↗
• MalfunctionDec 31, 2019Material Deformation; Material Deformation

  THE DEVICE WAS USED FOR ERBD WITH THE APPROACH FROM THE DUODENAL PAPILLA. AFTER PLACING A WIRE GUIDE (VISIGUIDE 0.025 INCH/OLYMPUS) AT THE COMMON BILE DUCT, THE PHYSICIAN ATTEMPTED TO STRAIGHTEN THE COMPLAINT DEVICE WITH THE PIGTAIL STRAIGHTENER AND TO MADE IT FOLLOW THE WIRE GUIDE. HOWEVER, HE COULD NOT DO THAT BECAUSE THE PIG TAIL PART GOT KINKED. THEREFORE, THE PROCEDURE WAS COMPLETED WITH ZEBD-7-4.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9535581 ↗
• MalfunctionDec 18, 2019Material Deformation; Material Deformation

  THE PHYSICIAN NOTICED THAT THE PIGTAIL APPEARED TO BE DENTED BEFORE OPENING THE PACKAGE OF THE DEVICE, THEN HE CONFIRMED THE DENT WHEN HE OPENED THE PACKAGE. ANOTHER ZEBD-7-7 WAS USED INSTEAD. (B)(6) 2019, (B)(6) ): THE PHYSICIAN NOTICED THAT THE PIGTAIL APPEARED TO BE DENTED BEFORE OPENING THE PACKAGE OF THE DEVICE, THEN HE CONFIRMED THE DENT WHEN HE OPENED THE PACKAGE. THE USER TRIED TO ADVANCE THE STENT OVER A WIRE GUIDE DESPITE THE DENT, BUT IT COULD NOT BE USED DUE TO DAMAGES IN THE PIGTAIL. ANOTHER ZEBD-7-7 WAS USED INSTEAD. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/ BENT'.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9488276 ↗
• MalfunctionDec 4, 2019Material Deformation; Material Deformation

  THE USER STRAIGHTENED THE STENT(ZEBD-7-7 LOT C1509130) WITH THE STRAIGHTENER AND STARTED TO ADVANCE THE STENT OVER OLYMPUS'S VISIGLIDE 0.025" BUT THE STENT KINKED AND THE WIRE GUIDE CAME OUT FROM THE STENT'S SIDE HOLE, SO HE USED ANOTHER ZEBD-7-7 INSTEAD AND THE PROCEDURE WAS COMPLETED. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT¿.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9409774 ↗
• MalfunctionNov 25, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  1ST DEVICE [THIS PR]: PIGTAIL OF ONE ZEBD-7-7/ LOT# C1609172 WAS STRAIGHTENED WITH A STRAIGHTENER, BUT A WIRE GUIDE (OLYMPUS/ VIGIGLIDE 0.025INCH) COULD NOT BE ADVANCED THROUGH THE PIGTAIL DUE TO KINKS. THE DEVICE WAS REPLACED WITH ANOTHER ZEBD-7-7/ LOT# UNKNOWN (= THE 2ND DEVICE BELOW). 2ND DEVICE [2ND PR CREATED FOR THE FOLLOWING]: THE USER ATTEMPTED TO USE ONE ZEBD-7-7/ LOT# UNKNOWN THOUGH, THE PIGTAIL BECAME KINKED. THE DEVICE WAS REPLACED WITH ANOTHER ZEBD-7-10/ LOT# UNKNOWN (= THE 3RD DEVICE BELOW). 3RD DEVICE [3RD PR CREATED FOR THE FOLLOWING]: PIGTAIL OF ONE ZEBD-7-10/ LOT# UNKNOWN WAS STRAIGHTENED WITH A STRAIGHTENER, BUT THE WIRE GUIDE COULD NOT BE ADVANCED THROUGH THE PIGTAIL DUE TO KINKS. SINCE THE PIGTAIL OF THE 2ND DEVICE WAS LESS KINKED, THE USER DECIDED TO USE THE 2ND DEVICE AND PLACED IT IN THE BILE DUCT TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9368302 ↗
• MalfunctionOct 10, 2019Material Deformation; Material Deformation

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/ BENT'. WHEN THE USER WAS STRAIGHTENING THE PIGTAIL WITH THE STRAIGHTENER, THE STENT BECAME KINKED. THE STENT DID NOT TOUCH A WIRE GUIDE. THEREFORE, ANOTHER ZEBD-7-7 WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9176913 ↗
• MalfunctionOct 8, 2019Material Deformation; Material Deformation

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/ BENT'. AFTER PLACING OLYMPUS'S WIRE GUIDE VISIGLIDE 0.025INCH IN THE COMMON BILE DUCT, THE USER ADVANCED THE ZEBD- STENT OVER THE WIRE GUIDE. HOWEVER, THE WIRE GUIDE COULD NOT PASS THROUGH THE STENT SINCE THE PIGTAIL BECAME KINKED. THE STENT WAS REPLACED WITH ANOTHER MANUFACTURER'S ERBD STENT AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9165523 ↗
• MalfunctionSep 30, 2019Material Deformation; Material Deformation

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. AN ADDITIONAL FILE WAS CREATED TO CAPTURE THE SECOND LOT NUMBER. THE USER STRAIGHTENED THE PIGTAIL (C1603512 OR C1603853) AND ADVANCED OVER A 0.025" WIRE GUIDE. HOWEVER, THE STENT STOPPED ADVANCING SINCE THE PIGTAIL BECAME KINKED. ANOTHER ZEBD-7-7 (C1603512 OR C1603853) WAS USED INSTEAD THOUGH, THE SAME THING OCCURRED. THEREFORE, ZEBD-7-4 WAS USED INSTEAD TO COMPLETE THE PROCEDURE. (IT CANNOT BE DETERMINED WHICH LOT WAS THE FIRST OR SECOND.) THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9137074 ↗
• MalfunctionSep 30, 2019Material Deformation; Material Deformation

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. AN ADDITIONAL FILE WAS CREATED TO CAPTURE THE SECOND LOT NUMBER. THE USER STRAIGHTENED THE PIGTAIL (C1603512 OR C1603853) AND ADVANCED OVER A 0.025" WIRE GUIDE. HOWEVER, THE STENT STOPPED ADVANCING SINCE THE PIGTAIL BECAME KINKED. ANOTHER ZEBD-7-7 (C1603512 OR C1603853) WAS USED INSTEAD THOUGH, THE SAME THING OCCURRED. THEREFORE, ZEBD-7-4 WAS USED INSTEAD TO COMPLETE THE PROCEDURE. (IT CANNOT BE DETERMINED WHICH LOT WAS THE FIRST OR SECOND.) THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9137002 ↗
• MalfunctionSep 23, 2019Material Deformation; Material Deformation

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. DURING THE PREPARATION FOR THE PROCEDURE, THE PHYSICIAN NOTICED THERE WAS A BURR ON THE EDGE OF THE STENT AND DECIDED IT WAS DANGEROUS. THEREFORE, THE COMPLAINT DEVICE WAS EXCHANGED WITH ANOTHER MANUFACTURER¿S STENT TO COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE DID NOT CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION ON SEP 10TH BY (B)(6): REGARDING WHAT "BURR" IS, I RECEIVED ADDITIONAL INFORMATION FROM THE REP. THE PHYSICIAN¿S COMMENT: THE DOCTOR INDICATES THAT ¿BURR¿ IS AT THE HOLE WHICH SEEMS TO BE CREATED BY PERFORATING OF A WIRE GUIDE. HOWEVER, THE DOCTOR SAYS THAT HE DID NOT INSERT A WIRE GUIDE INTO THE DEVICE. WHEN HE OPENED THE PACKAGE, THE DEVICE ALREADY HAD THE HOLE AND BURR. SALES REP¿S COMMENT: I CHECKED THE PHOTOS OF THE RETURNED DEVICE. AS POINTED OUT BY CR TEAM OF JAPAN, IT SEEMED THAT A WIRE GUIDE WAS USED AND PERFORATED THE DEVICE THOUGH THE PHYSICIAN SAYS HE DID NOT USE A WIRE GUIDE. I ACCEPT ANY INVESTIGATION RESULTS. YOU CAN WRITE THE RESULTS AS THEY ARE IN THE CUSTOMER REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9103370 ↗
• MalfunctionSep 23, 2019Material Deformation; No Apparent Adverse Event; Material Deformation; No Apparent Adverse Event

  THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. BASED ON LIMITED INITIAL INFORMATION, THE EVENT WAS ASSESSED CAUTIOUSLY AS REPORTABLE BASED ON THE FDA REPORTING PRECEDENCE FOR "STENT KINKED/BENT". FOLLOWING DEVICE EVALUATION IT HAS BEEN CONFIRMED THAT THIS MALFUNCTION HAS NOT OCCURRED. NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. THE DEVICE HAS BEEN EVALUATED AND NO DEFECT WAS OBSERVED- THIS DEVICE WAS NOT USED ON A PATIENT. A KINK WAS CONFIRMED UPON OPENING THE PACKAGING OF THE DEVICE, SO IT WAS REPLACED WITH ANOTHER ZEBD-7-7 (LOT: UNKNOWN) AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 9102717 ↗
• MalfunctionSep 12, 2019Material Deformation; Material Deformation

  THE DEVICE WAS REMOVED FROM THE PACKAGING FOR USE AND NOTED TO BE BENT. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE BEND DOES NOT HAVE SHARP EDGES. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9009875 ↗
• MalfunctionSep 12, 2019Material Deformation; Material Deformation

  THE DEVICE WAS REMOVED FROM THE PACKAGING FOR USE AND NOTED TO BE BENT. THE WIRE WOULD NOT ADVANCE THROUGH THE DEVICE. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE BEND DOES NOT HAVE SHARP EDGES. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9009687 ↗
• MalfunctionAug 23, 2019Material Deformation; Material Deformation

  WHEN THE USER WAS STRAIGHTENING THE PIGTAIL WITH A STRAIGHTENER, HE NOTICED A KINK/KINKS AT A DRANAGE HOLE/HOLES. THE DEVICE WAS DISPOSED OF AND ANOTHER MANUFACTURER'S STENT WAS USED INSTEAD. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Patient Involvement

  MAUDE report 8924447 ↗
• MalfunctionAug 22, 2019Material Deformation; Material Deformation

  PRIOR TO PATIENT CONTACT, THE USER ATTEMPTED TO STRAIGHTEN ZEBD-7-7/ C1594654 WITH THE STRAIGHTENER BUT THE STENT KINKED DURING THE ATTEMPT. ANOTHER DEVICE WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8921248 ↗
• MalfunctionJul 30, 2019Material Deformation; Material Deformation

  AFTER THEY PLACE THE GUIDE WIRE, THEY TRY TO PUT THE STENT INTO THE GUIDE WIRE, THEY FOUND THE STENT PIGTAIL PART IS KINK, SO THEY USE ANOTHER NEW PACKAGE, AFTER THEY OPEN ANOTHER NEW PACKAGE THEY FOUND THE STENT PIGTAIL PART IS KINK AS WELL, SO THEY USE ANOTHER NEW PACKAGE AND THIS ONE IS OK! FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8843949 ↗
• MalfunctionJul 30, 2019Material Deformation; Material Deformation

  AFTER THEY PLACE THE GUIDE WIRE, THEY TRY TO PUT THE STENT INTO THE GUIDE WIRE, THEY FOUND THE STENT PIGTAIL PART IS KINK, SO THEY USE ANOTHER NEW PACKAGE, AFTER THEY OPEN ANOTHER NEW PACKAGE THEY FOUND THE STENT PIGTAIL PART IS KINK AS WELL, SO THEY USE ANOTHER NEW PACKAGE AND THIS ONE IS OK! FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8843925 ↗
• MalfunctionJul 30, 2019Material Deformation; Material Deformation

  WHEN THE USER ATTEMPTED TO LOAD THE STENT OVER ANOTHER MANUFACTURER'S WIRE GUIDE WITH STRAIGHTENING THE PIGTAIL WITH THE STRAIGHTENER, THE STENT BECAME KINKED. THEREFORE, ANOTHER ZEBD-7-7 WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8841442 ↗
• MalfunctionJul 24, 2019Material Deformation; Material Deformation

  THE USER STRAIGHTENED THE PIG TAIL USING THE STRAIGHTENER AND ATTEMPTED TO ADVANCE IT OVER A WIRE GUIDE(SIZE UNKNOWN), BUT THE WIRE GUIDE WOULD NOT GO THROUGH THE STENT LUMEN. HE THEN CHECKED THE STENT AND FOUND THE KINK IN THE PIG TAIL PART. HE REPLACED IT WITH ANOTHER STENT TO COMPLETE THE PROCEDURE. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8822176 ↗
• MalfunctionJul 22, 2019Material Deformation; Material Deformation

  THE USER STRAIGHTENED THE PIGTAIL WITH THE STRAIGHTENER AS USUAL AND ATTEMPTED TO ADVANCE IT OVER A WIRE GUIDE, BUT IT COULD NOT ADVANCE SINCE THE PIGTAIL BECAME KINKED. THE FIRST STENT. ANOTHER ZEBD-7-7 OF THE SAME LOT# WAS USED INSTEAD AS ABOVE, BUT THE SAME THING OCCURRED. THE SECOND STENT. THEREFORE, ANOTHER ZEBD-7-7 WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED WITH IT. THE THIRD STENT. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8811549 ↗
• MalfunctionJul 1, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE DEVICE WAS SELECTED AS A NEW STENT FOR THE PROCEDURE OF STENT EXCHANGE FOR PANCREATIC CYST DRAINAGE. THE CYST WAS LOCATED NEAR THE PANCREAS HEAD, SO APPROACH WAS GAINED FROM THE DUODENUM WITH ENDOSCOPE AT REVERSE ANGLE. 1. A PREVIOUSLY PLACED ZEBD-7-7 WAS GRASPED WITH GRASPING FORCEPS AND REMOVED WITH AN ENDOSCOPE (GIF2T240/ OLYMPUS) AS A UNIT. 2. AFTER AN ERCP CATHETER MANUFACTURED BY MTW WAS INSERTED INTO THE PANCREAS CYST FISTULA WITH ENDOSCOPE (GIF-H290, CHANNEL DIAMETER: 2.8MM/ OLYMPUS), A 0.025INCH WIRE GUIDE (VISIGLIDE2 ANGLE/ OLYMPUS) WAS ADVANCED TOO. THEN, THE COMPLAINT DEVICE (ZEBD-7-7/ LOT# C1572371) WAS ADVANCED THROUGH THE ENDOSCOPIC CHANNEL. (THE ENDOSCOPE WAS AT REVERSED ANGLE AT THIS TIME.) HOWEVER, THE STENT STOPPED ADVANCING AT APPROXIMATELY 5~10CM BEFORE THE DISTAL END OF THE SCOPE, SO THE ENDOSCOPE WITH THE STUCK STENT AND INSERTED WIRE GUIDE WAS REMOVED FROM THE PATIENT TO AVOID DAMAGE OF THE ENDOSCOPE. 3. THE ENDOSCOPE WAS CHANGED WITH A LARGE INTESTINE ENDOSCOPE (CF-H290, CHANNEL DIAMETER: 3.7MM/ OLYMPUS) FOR THE SECOND TRY. AFTER AN ERCP CATHETER WAS INSERTED INTO THE PANCREAS CYST FISTULA, A WIRE GUIDE FOLLOWED, THEN THE ERCP CATHETER WAS REMOVED. ANOT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8748473 ↗
• MalfunctionJun 26, 2019Material Deformation; Material Deformation

  THE USER STRAIGHTENED THE PIGTAIL AND ATTEMPTED TO ADVANCE IT OVER A WIRE GUIDE, BUT IT COULD NOT ADVANCE SINCE THE PIGTAIL BECAME KINKED. ANOTHER ZEBD-7-7 FROM STOCK WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8735260 ↗
• MalfunctionApr 12, 2019Material Deformation; Material Deformation

  THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT OVER BSJ'S WIRE GUIDE (JAGWIRE 0.035INCH 450CM STRAIGHT) WITH A STRAIGHTENER THOUGH, THE WIRE GUIDE COULD NOT TRANSIT THROUGH THE STENT DUE TO A KINK/KINKS IN THE STENT. THEREFORE, ANOTHER DEVICE WAS USED INSTEAD. (THE OPERATING ROOM WAS DARK, BUT THE PROCEDURE WAS CONDUCTED AS USUAL.) THERE HAVE BEEN NO ADVERSE EFFECT TO THE PATIENT REPORTED. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT' AND "STYLET WIRE/SHEATH PERFORATION". NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8507934 ↗