Zimmon G25794Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00827002257948), received between Aug 14, 2017 and Oct 29, 2025 — classified as 31 malfunctions.

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

• MalfunctionOct 29, 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 10-DEC-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23421030 ↗
• MalfunctionOct 28, 2025Material Twisted/Bent; Material Twisted/Bent

  DESCRIPTION OF EVENT UNABLE TO THREAD THE GUIDEWIRE THROUGH THE STENT AS THE STENT¿S MATERIAL FELT STIFFER THAN USUAL. HOWEVER, ANOTHER IDENTICAL STENT WAS USED WITHOUT ANY DIFFICULTIES. PATIENT/EVENT INFORMATION: NOTES: THE FOLLOWING INFORMATION WAS RECEIVED ON 13OCT2025: WHAT WAS THE SIZE OF THE WIREGUIDE USED IN THE PREPARATION STAGES? 0.035 JAG (BOSTON). PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. STORED IN 25 DEGREE CELSIUS ROOM. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES. 5 WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? YES. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE? INSPECTED AND NO DEFECTS. WHAT IS THE ENDOSCOPE MANUFACTURER, THE MODEL NUMBER AND WORKING CHANNEL SIZE THAT WAS USED FOR THE PROCEDURE? OLYMPUS TJF 160. ADDITIONAL FEEDBACK BY THE USER: "HE DOES FIND THAT ZEBD IS A BIT TOO STIFF IN GENERAL AND THIS PARTICULAR CASE, HE WAS SURPRISED HE HAD TROUBLE USING IT COS IT WAS STIFFER THAN HIS PAST EXPERIENCES WITH THE PRODUCT". ADDI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401697 ↗
• MalfunctionJul 17, 2025Improper or Incorrect Procedure or Method; Dent in Material; Improper or Incorrect Procedure or Method; Dent in Material

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 29-AUG-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529915 ↗
• MalfunctionFeb 6, 2020Material Perforation; Material Perforation

  THE STENT WAS STRAIGHTENED BY A STRAIGHTENER. WHEN ADVANCING THE STENT OVER A WIRE GUIDE, THE PROXIMAL TIP OF THE WIRE GUIDE PENETRATED THE STENT. THEREFORE, ANOTHER STENT WAS USED INSTEAD TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION ON JAN 17TH BY (B)(6). THE WIRE GUIDE USED IN THE PROCEDURE WAS 0.025-INCH ENDOSELECTOR PRODUCED BY BOSTON SCIENTIFIC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9676718 ↗
• MalfunctionDec 16, 2019Dent in Material; Material Deformation; Dent in Material; Material Deformation

  THE DEVICE WAS USED FOR EBD TREATING OBSTRUCTIVE JAUNDICE. WHEN THE USER ADVANCED THE STENT OVER THE WIRE GUIDE, IT BECAME KINKED NEAR THE DISTAL TIP OF THE WIRE GUIDE. THE STRAINER WAS USED. ANOTHER MANUFACTURER'S DEVICE 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 9472532 ↗
• MalfunctionDec 9, 2019Material Deformation; Material Deformation

  WHEN THE USER WAS ADVANCING THE STENT OVER A WIRE GUIDE WITH STRAIGHTENING THE PIGTAIL WITH A STRAIGHTENER, THE PIGTAIL BECAME KINKED. ANOTHER SIZED STENT WAS USED INSTEAD FOR THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. 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 9436839 ↗
• MalfunctionNov 25, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  1ST DEVICE [2ND PR CREATED TO CAPTURE THIS]: 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 [3RD PR CREATED TO CAPTURE THIS]: 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 [THIS PR]: PIGTAIL OF ONE ZEBD-7-10/ LOT# C1632925 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 9368351 ↗
• MalfunctionNov 14, 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'. THE USER ADVANCED OLYMPUS/ VISIGLIDE WIRE GUIDE 0.025" TO B2 (BILE DUCT). THEN THE USER STRAIGHTENED THE PIG TAIL WITH THE STRAIGHTENER (ZEBD-7-10/ LOT C1626419) AND ATTEMPTED TO ADVANCE IT OVER THE WIRE GUIDE BUT FAILED. THE USER FOUND A KINK ON THE PIG TAIL. ANOTHER ZEBD-7-10 WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9322041 ↗
• MalfunctionAug 1, 2019Material Deformation; Material Deformation

  PIG TAIL OF ZEBD-7-10/ LOT C1563490 KINKED AND THE USER STOPPED USING THE DEVICE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. [UPDATED ON 17/JULY/2019 (B)(4)] THE USER STRAIGHTENED THE PIGTAIL(ZEBD-7-10/ LOT C1563490) WITH THE STRAIGHTENER(ZEBD-7-10/ LOT C1563490) AND ATTMPTED TO ADVANCE THE PIGTAIL OVER OLYMPUS'S VISIGLIDE 0.025" BUT IT DID NOT ADVANCE. THE USER CHECKED THE PIGTAIL AND FOUND A KINK, SO THE USER STOPPED USING THE DEVICE. ANOTHER ZEBD-7-10 WAS USED INSTEAD. 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 8850306 ↗
• MalfunctionJul 24, 2019Material Deformation; Material Deformation

  PRIOR TO PATIENT CONTACT, ZEBD-7-10/ LOT C1572742 KINKED. [UPDATED ON 02/JULY/2019] THE USER STRAIGHTENED ZEBD-7-10/ LOT C1572742 WITH THE STRAIGHTENER CONTAINED IN ZEBD-7-10 AND THEN HE ATTEMPTED TO ADVANCE THE PIGTAIL CATHETER OVER VISIGLIDE2 0.025" /OLYMPUS BUT THE CATHETER DID NOT ADVANCE. THEREFORE HE CHECKED THE STENT AND FOUND A KINK IN THE STENT. 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 8822077 ↗
• MalfunctionJul 9, 2019Material Deformation; Material Deformation

  UPDATED ON 12/JUNE/2019 BY (B)(4)): ZEBD-7-10/LOT C1366184 WAS STRAIGHTENED WITH USING THE STRAIGHTENER AND ADVANCED OVER A WIRE GUIDE BUT THE STENT STOPPED ADVANCING. THE USER CHECKED THE STENT AND HE FOUND A KINK IN THE STENT. THEREFORE HE DECIDED NOT TO USE THE STENT AND ANOTHER ZEBD-7-10 WAS USED INSTEAD. 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 8771355 ↗
• MalfunctionJul 3, 2019Material Deformation; Material Deformation

  OLYMPUS'S VISIGLIDE 0.025" WAS ADVANCED TO THE BILE DUCT AND THEN, THE USER ATTEMPTED TO ADVANCE ZEBD-7-10/ LOT C1601707 OVER THE WIRE GUIDE. HOWEVER, THE STENT KINKED WHEN THE USER WAS STRAIGHTENING THE PIG TAIL USING THE STRAIGHTENER AND THE USED COULD NOT ADVANCE THE STENT OVER THE WIRE GUIDE DUE TO THE KINK. ANOTHER DEVICE (ZEBD-7-7) WAS USED INSTEAD FOR THE PROCEDURE 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 8757328 ↗
• MalfunctionJul 3, 2019Material Deformation; Material Deformation

  THE PIGTAIL WAS STRAIGHTENED WITH A STRAIGHTENER FIRST. WHEN THE USER WAS ADVANCING THE STENT OVER ANOTHER MANUFACTURER'S WIRE GUIDE (REVOWAVE 0.025INCH ANGLE/ BY PIOLAX), HE FELT RESISTANCE. HE CHECKED THE DEVICE, THEN FOUND KINKS IN THE PIGTAIL WHICH PREVENTED THE WIRE GUIDE FROM BEING ADVANCED THROUGH THE STENT. HE STOPPED USING THE DEVICE IN ORDER TO AVOID RISKS FOR PLACING THE KINKED STENT. ANOTHER ZEBD-7-10 (LOT# UNKNOWN) WAS PLACED 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 8757297 ↗
• MalfunctionJun 13, 2019Material Deformation; Material Deformation

  THE USER OPENED THE PACKAGE OF ZEBD-7-10/ LOT C1413174 AND HE ATTEMPTED TO ADVANCE THE PIG TAIL STENT OVER A WIRE GUIDE BUT HE FOUND A KINK IN THE STENT, SO HE USED ANOTHER PRODUCT INSTEAD AND COMPLETED 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 8695672 ↗
• MalfunctionApr 25, 2019Material Deformation; Material Deformation

  USER DETECTED THE STENT BENT SERIOUSLY BEFORE ADVANCING THROUGH ENDOSCOPY. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8550252 ↗
• MalfunctionApr 18, 2019Material Deformation; Material Deformation

  THERE IS A KINK IN THE PIGTAIL OF THE STENT AND IT CAUSED THE DIFFICULTY IN ADVANCING IT OVER A WIRE GUIDE. ANOTHER STENT WAS USED INSTEAD FOR THE PROCEDURE. [DESCRIPTION OF EVENT WAS REVISED BY THE REP AS BELOW ON 28/MAR/2019]: THE USER STRAIGHTENED THE PIG TAIL USING THE STRAIGHTENER BUT IT KINKED. HE CHECKED IF IT STILL COULD ADVANCE OVER A WIRE GUIDE (OLYMPUS' VISIGLIDE2 / SIZE UNKNOWN) BUT THE WIRE GUIDE WOULD NOT PASS THE KINKED PART. ANOTHER STENT WAS USED INSTEAD FOR 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 8527857 ↗
• MalfunctionJan 10, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT" AND "DIFFICULT ADVANCEMENT". THE DEVICE WAS TO BE USED FOR STENT PLACEMENT IN THE INTRAHEPATIC BILE DUCT. AFTER PLACING BOSTON'S WIRE GUIDE "PATHCOURSE 0.025INCH" IN THE B2 AREA, THE PHYSICIAN STRAIGHTENED THE STENT WITH THE STRAIGHTENER IN ORDER TO ADVANCE THE STENT OVER THE WIRE GUIDE. HOWEVER, BECAUSE THE WIRE GUIDE COULD NOT PASS THROUGH THE STENT DUE TO KINK, ANOTHER STENT WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8235944 ↗
• MalfunctionDec 20, 2018Material Deformation; Material Deformation

  THIS FILE IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/ BENT' THE USER STRAIGHTENED THE PIG TAIL USING THE STRAIGHTENER AND ATTEMPTED TO ADVANCE IT OVER A WIRE GUIDE (OLYMPUS' VISIGLIDE 0.025INCH), BUT THE WIRE GUIDE WOULD NOT BE INSERTED INTO THE STENT LUMEN, THEN THE USER FOUND THE PIG TAIL WAS KINKED. ANOTHER ZEBD-7-10 WAS USED INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8184433 ↗
• MalfunctionSep 25, 2018Material Deformation; Material Deformation

  THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT KINKED/ BENT" THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT OVER OLYMPUS'S WIRE GUIDE (VISIGLIDE 0.025INCH ANGLE) 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. THERE HAVE BEEN NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7905018 ↗
• MalfunctionJul 25, 2018Material Deformation; Material Deformation

  AFTER PLACING OLYMPUS'S 0.025 INCH VISIGLIDE 2 IN THE INTRAHEPATIC BILE DUCT, THE PHYSICIAN STRAIGHTENED ZEBD-7-10/ LOT# C1423528 ((B)(4)) WITH THE STRAIGHTENER IN ORDER TO ADVANCE IT OVER THE WIRE GUIDE. THEN, THE PIGTAIL GOT KINKED, SO IT WAS REPLACED WITH ANOTHER ZEBD-7-10/ LOT# C1362625 ((B)(4)). HOWEVER, THE SAME THING OCCURRED ON THE ZEBD-7-10/ LOT# C1362625. THEREFORE, BOSTON SCIENTIFIC'S STENT FLEXIMA 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 7718517 ↗
• MalfunctionJul 25, 2018Material Deformation; Material Deformation

  AFTER PLACING OLYMPUS'S 0.025 INCH VISIGLIDE 2 IN THE INTRAHEPATIC BILE DUCT, THE PHYSICIAN STRAIGHTENED ZEBD-7-10/ LOT# C1423528 WITH THE STRAIGHTENER IN ORDER TO ADVANCE IT OVER THE WIRE GUIDE. THEN, THE PIGTAIL GOT KINKED, SO IT WAS REPLACED WITH ANOTHER ZEBD-7-10/ LOT# C1362625. HOWEVER, THE SAME THING OCCURRED ON THE ZEBD-7-10/ LOT# C1362625. (ANOTHER COMPLAINT WAS OPENED TO ADDRESS THE FAILURE WITH THE SECOND DEVICE) THEREFORE, BOSTON SCIENTIFIC'S STENT FLEXIMA 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 7718506 ↗
• MalfunctionMar 27, 2018Kinked; Kinked

  THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT OVER A WIRE GUIDE AFTER STRAIGHTENING THE STENT WITH THE STRAIGHTENER, BUT THE STENT WOULD NOT ADVANCE OVER THE WIRE GUIDE. THEN, IT WAS CONFIRMED THAT THE KINK IN THE PIGTAIL OF THE STENT. ANOTHER DEVICE (SAME LOT #) WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7373112 ↗
• MalfunctionMar 15, 2018Kinked; Kinked

  THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT OVER A WIRE GUIDE AFTER STRAIGHTENING THE STENT WITH THE STRAIGHTENER, BUT THE STENT WOULD NOT ADVANCE OVER THE WIRE GUIDE. THEN, IT WAS CONFIRMED THAT THE KINK IN THE PIGTAIL OF THE STENT. THE USER TRIED THE SAME AGAIN (ATTEMPTED TO ADVANCE THE STENT OVER THE WIRE GUIDE AFTER STRAIGHTENING THE STENT WITH THE STRAIGHTENER), BUT IT WOULD NOT ADVANCE THROUGH. ANOTHER DEVICE (LOT # UNKNOWN) WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7341606 ↗
• MalfunctionDec 12, 2017Bent; Kinked; Bent; Kinked

  AFTER STRAIGHTENED THE PIGTAIL USING THE STRAIGHTENER AS USUAL, THE USER ATTEMPTED TO ADVANCE THE STENT OVER A WIRE GUIDE BUT IT WOULD NOT. HE FOUND THE STENT HAD A KINK IN PIG TAIL, SO HE REPLACED IT WITH ANOTHER ZEBD-7-10 (LOT UNKNOWN) TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7107518 ↗
• MalfunctionOct 27, 2017Bent; Kinked; Bent; Kinked

  THOUGH THE PHYSICIAN ATTEMPTED TO INSERT THE STENT OVER A WIRE GUIDE WITH STRAIGHTENING THE PIGTAIL, THE WIRE GUIDE WOULD NOT PASS THROUGH THE STENT LUMEN, THEN A KINK WAS NOTED. THEREFORE, THE DEVICE WAS CHANGED WITH ANOTHER ZEBD-7-10 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 6983119 ↗