Evolution G48027Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10827002480275), received between Nov 9, 2016 and Jan 23, 2025 — classified as 4 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (10 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Material Twisted/Bent; Material Twisted/Bent

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 7 JUL 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218329 ↗
• MalfunctionDec 17, 2024Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 30 MAY 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20951766 ↗
• InjuryJun 28, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 03-JAN-2025.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19631095 ↗
• MalfunctionNov 20, 2023Material Twisted/Bent; Material Twisted/Bent

  USER ADVANCED THE STENT DELIVERY SYSTEM TO DESIRED POSITION, THEN PULLED THE TRIGGER BUT FOUND OUT THE STENT CANNTO BE DEPLOYED. USER CHANGED TO ANOTHER SAME STENT TO COMPLETE THE PROCEDURE. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169880 ↗
• MalfunctionFeb 28, 2023Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  THE STENT DID NOT OPEN PROPERLY IN THE DESIRED DUCT. QUERY REPLY WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS SCOPE WITH 4.2 MM CHANNEL. DETAILS OF THE WIRE GUIDE USED 0.035 INCH TRACER METRO. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? YES PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. DUODENUM. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? 30-35%. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO. WHAT INTERVENTION (IF ANY) WAS REQUIRED? N/A. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? SAME PROCEDURE. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? NO. IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED. N/A. STRICTURE INFORMATION: WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? 6 CM. WHERE WAS THE STRICTURE LOCATED IN THE BODY? DUODENUM. WAS THERE RESISTANCE FELT PASSING WIRE GUIDE THROUGH STRICTURE? NO. WAS THERE RESISTANCE FELT PASSING THE EVOLUTION THROUGH STRICTURE? NO. WAS TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451616 ↗
• MalfunctionDec 22, 2022Break; Material Deformation; Break; Material Deformation

  USER OPENED THE PACKAGE, AND FELT OBVIOUS RESISTANCE WHILE DEPLOY STENT. USER RETRACTED THE DEVICE FROM PATIENT AND FOUND OUT THE CONJUNCTION BETWEEN SHEATH AND HANDLE BENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. 1. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR?(WHEN UNPACKING OR PREPARING THE EVOLUTION, WHILE INSERTING THE EVOLUTION IN THE PATIENT, DURING STENT PLACEMENT, WHILE REMOVING THE INTRODUCER, OR DURING STENT REPOSITIONING/REMOVAL) STENT PLACEMENT. 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS DUODENOSCOPE. 3. WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? OPEN. 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? 0.035'' WIRE GUIDE(MICROPORT). 5. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? NO. 6. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? YES. 7. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. DUODENAL PAPILLA. 8. HOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16032877 ↗
• MalfunctionApr 13, 2022Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  EXCERPTED FROM CUSTOMER'S EMAIL TO THE REP: WE ATTEMPTED TO USE THE 12CM DUODENAL STENT 10FR TODAY HOWEVER WE WERE UNABLE TO DEPLOY THE STENT. IT WAS NOTED THAT COVERING JUST ABOVE THE DISTAL TIP OF THE STENT WAS NOT INTACT. TAKEN FROM THE COMPLAINT FORM: DURING THE PROCEDURE, NO GUIDE WIRE WAS PLACED. THE DUODENAL 12CM STENT WAS POSITIONED IN THE DUODENUM. HOWEVER; DEPLOYMENT WAS STOPPED AS THE TEAM FELT THERE WAS AN ISSUE DEPLOYING THE STENT. AS THE 12CM DUODENAL STENT WAS NOT FULLY DEPLOYED, IT WAS REMOVED WITHOUT INCIDENCE STILL ATTACHED TO THE DELIVERY MECHANISM. ANOTHER 9CM DUODENAL STENT PRODUCT CODE EVO-22-27-9-D LOT C1878169. WAS IMPLANTED INSTEAD WITHOUT ANY DIFFICULTY. NO UNINTENDED PART OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102911 ↗
• MalfunctionNov 7, 2021Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  SUPPLEMENTAL REPORT REQUIRED TO PROVIDE DETAILS OF DEVICE EVALUATION ON (B)(6) 2021. "STENT FULLY DEPLOYED + DAMAGED. PROXIMAL FLEXOR KINKED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758503 ↗
• MalfunctionOct 12, 2021Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12613716 ↗
• MalfunctionJun 3, 2021Break; Structural Problem; Break; Structural Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11928552 ↗
• MalfunctionJan 15, 2021Break

  FOLLOW UP REPORT REQUIRED TO CAPTURE THE BELOW ADDITIONAL INFORMATION: DEVICE EVALUATED ON (B)(6) 2021: "POLYIMIDE TO RETRIEVAL LOOP BROKEN. YELLOW MARKER SEPARATED/DETACHED".

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 11176441 ↗
• MalfunctionDec 10, 2020Break; Break

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

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

  MAUDE report 10987981 ↗
• MalfunctionDec 1, 2020Break; Break

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

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

  MAUDE report 10927547 ↗
• MalfunctionSep 1, 2020Break; Material Deformation; Break; Material Deformation

  CUSTOMER DEPLOYED STENT WHEN THEY GOT TO THE END THERE WAS A CLINKING SOUND, AND WHEN REMOVED THEY COULD SEE THE END WAS FRAYED, STILL INSIDE THE PATIENT.

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

  MAUDE report 10475620 ↗
• MalfunctionJul 27, 2020Break; Activation Problem; Break; Activation Problem

  STENT CANNOT BE DEPLOYED. PATIENT OUTCOME: "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE." PATIENT/EVENT INFO - NOTES: 1. WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? METII-35-480; COOK METII-35-480. 2. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? WITH ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH PATIENT) ALSO ASK: 3. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED DURING THE PROCEDURE? OLYMPUS GF-H260AI. GF-H260AI. 4. HAD DILATION OF THE STRICTURE BEEN PERFORMED PRIOR TO STENT PLACEMENT? NO. 5. WHAT WAS THE DIAMETER OF THE STRICTURE AT THE TIME OF STENT PLACEMENT (IN MM)? 1.4CM. MM) 1.4CM. 6. WHAT WAS THE LENGTH OF THE STRICTURE AT THE TIME OF STENT PLACEMENT (IN CM)? 6CM. CM) 6CM. 7. PLEASE DESCRIBE THE LOCATION IN THE BODY WHERE THE STENT WAS TO BE PLACED. PYLORUS. 8. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE THROUGH THE STRICTURE? NO. 9.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10326987 ↗
• MalfunctionJun 17, 2020Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  PER REP - (B)(6) 2020 - THE DEVICE DID NOT DEPLOY AS EXPECTED. PER CUSTOMER - (B)(6) 2020 - AFTER PUTTING THE TOME DOWN THE SCOPE, THE CUTTING WIRE ON THE SPHINCTERTOME BROKE WHEN THE TOME WAS FLEXED. PATIENT OUTCOME: THE CUSTOMER HAS BEEN ASKED TO PROVIDE THE ANSWERS TO THE FOLLOWING QUESTIONS. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? -NO IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? -NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? -NO. IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? -NO. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? -NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? -NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. PATIENT/EVENT INFO - NOTES: THE CUSTOMER HAS BEEN ASKED TO PROVIDE THE ANSWERS TO THE FOLLOWING QUESTIONS. 1.1 GENERAL QUESTIONS: 1.1.1 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? AT THE END OF THE PROCEDURE. WHEN UNPACKI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10165230 ↗
• MalfunctionApr 6, 2020Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  USER ADVANCED THE DEVICE THROUGH WIRE GUIDE TO DESIRED POSITION AND DETECTED THE STENT CANNOT BE RELEASED FROM DELIVERY SYSTEM, AND THEN USER PULLED OUT THE SAFETY WIRE AND STILL CANNOT RELEASE THE STENT. USER THEN CHANGED WITH A SIMILAR DEVICE FROM MICROTECH TO FINISH THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9928910 ↗
• MalfunctionSep 12, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PATIENT'S STENOSIS IS 8 CM LONG. USER CANNOT SEE THE STENT UNDER X-RAY IMAGE DURING STENT DEPLOYMENT, AND THERE WAS A SOUND LIKE SLAM WHILE THE MARKER AT 1/3 POSITION, BUT USER DIDN'T STOP DEPLOYMENT AFTER THE SOUND AND PULLED THE SAFETY WIRE OUT. THE STENT CANNOT BE SAW DURING THE WHOLE DEPLOYMENT BECAUSE OF THE CONTRAST ACCUMULATION, AND THE YELLOW MARKER CANNOT BE SAW EITHER BECAUSE IT WAS COVERED BY EXCREMENT. USER COMPLETE THE DEPLOYMENT OF STENT BY EXPERIENCE UNTIL MARKER REACHED TERMINAL POINT AND THE TRIGGER CANNOT BE PULLED. USER RETRACTED THE DEVICE FROM PATIENT AFTERWARD AND FOUND OUT THE STENT WAS STILL INSIDE SHEATH. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.

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

  MAUDE report 9009407 ↗
• MalfunctionAug 1, 2019Activation Failure; Activation Failure

  STENT PLACEMENT WAS PERFORMED TO TREAT STENOSIS (FROM BELOW DUODENAL BULB TO SECOND PORTION) DUE TO PANCREATIC CANCER. EVO-22-27-12-D/ C1570803 WAS ADVANCED TO THE DESIRED POSITION AND THE USER STARTED DEPLOYING THE STENT FROM DISTAL SIDE. HOWEVER, THE TIP OF THE STENT DID NOT EXPAND EVEN THOUGH THERE WAS NO STENOSIS AROUND THE TIP OF THE STENT. THE USER DEPLOYED THE STENT UNTIL REACHING POINT-OF-NO-RETURN BUT THE TIP OF THE STENT STILL DID NOT EXPAND, SO THE DELIVERY SYSTEM WAS REMOVED FROM THE BODY. THE USER ATTEMPTED TO DEPLOY THE TIP OF THE STENT OUTSIDE THE BODY AND IT EXPANDED LIKE FLARE SHAPE.(THIS SENTENCE MEANS THE TIP OF THE STENT EXPANDED WITHOUT PROBLEMS OUTSIDE THE BODY.) ANOTHER EVO-22-27-12-D/ C1570803 WAS USED BUT THE SAME THING WAS HAPPENED, SO THE PROCEDURE WAS ABORTED. STENT PLACEMENT WITH USING COMPETITOR'S STENT OR SURGERY WILL BE PERFORMED. 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 NOT EXPANDING / OPENING POST DEPLOYMENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8850289 ↗
• MalfunctionApr 15, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNKNOWN AGE AND GENDER UNDERWENT AN UPPER ENDOSCOPY WITH PLACEMENT OF DUODENAL STENT WHICH THE EVOLUTION DUODENAL CONTROLLED-RELEASE STENT, G48027- QTY. 2 WERE USED. (AN ADDITIONAL FILE HAS BEEN CREATED TO CAPTURE THE SECOND DEVICE) BOTH STENTS WERE PREPPED CORRECTLY. BOTH WERE PASSED DOWN THE SCOPE. WHEN ASKED TO DEPLOY, THE TRIGGER WAS SQUEEZED AND THE LITTLE PLASTIC PIECE MOVED DOWN THE HANDLE, BUT THE CATHETER DID NOT MOVE AND THE STENT DID NOT DEPLOY. THERE WAS AN AUDIBLE CLICK WITH THE SECOND STENT. THE POSITION WAS GOOD AND SCOPE WAS STRAIGHT INSIDE. DR. REPORTED THE SCOPE WAS NOT LOOPED TIGHT ON THE OUTSIDE. THIS IS THE MESSAGE THAT WAS SENT TO ME [DISTRICT MANAGER] FROM THE NURSE. THE REFERENCE TO THE LITTLE PLASTIC PIECE ON THE HANDLE IS THE INDICATOR FOR WHERE THEY ARE IN THE DEPLOYMENT. THE PROCEDURE WAS COMPLETED BY USING A THIRD STENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8514469 ↗
• MalfunctionApr 15, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS FOLLOW UP REPORT IS BEING SCHEDULED TO CANCEL THE INITIAL MDR. AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNKNOWN AGE AND GENDER UNDERWENT AN UPPER ENDOSCOPY WITH PLACEMENT OF DUODENAL STENT WHICH THE EVOLUTION DUODENAL CONTROLLED-RELEASE STENT, (B)(4) WERE USED. (AN ADDITIONAL FILE WAS CREATED TO CAPTURE THE SECOND DEVICE) BOTH STENTS WERE PREPPED CORRECTLY. BOTH WERE PASSED DOWN THE SCOPE. WHEN ASKED TO DEPLOY, THE TRIGGER WAS SQUEEZED AND THE LITTLE PLASTIC PIECE MOVED DOWN THE HANDLE, BUT THE CATHETER DID NOT MOVE AND THE STENT DID NOT DEPLOY. THERE WAS AN AUDIBLE CLICK WITH THE SECOND STENT. THE POSITION WAS GOOD AND SCOPE WAS STRAIGHT INSIDE. DR. REPORTED THE SCOPE WAS NOT LOOPED TIGHT ON THE OUTSIDE. THIS IS THE MESSAGE THAT WAS SENT TO ME [DISTRICT MANAGER] FROM THE NURSE. THE REFERENCE TO THE LITTLE PLASTIC PIECE ON THE HANDLE IS THE INDICATOR FOR WHERE THEY ARE IN THE DEPLOYMENT. THE PROCEDURE WAS COMPLETED BY USING A THIRD STENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8514438 ↗
• MalfunctionOct 1, 2018Break; Material Deformation; Break; Material Deformation

  THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE" THE EXACT LOT NUMBER IS NOT KNOWN HE WILL INFORM OF THIS LATER. THE PRODUCT WAS USED TODAY AND THE STENT BROKE. "AS PER COMPLAINT FORM": DURING A CONTROLLING, THE NEW STENT AFTER 4 WEEKS, THE PHYSICIAN FIND A DISINTEGRATED STENT, IN THE ORIGINAL POSITION. AT LEAST ON 4 POSITONS WAS THE STENT BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7922333 ↗
• InjuryAug 28, 2018Fracture; Fracture

  REPORT IS BEING SUBMITTED UNDER SERIOUS INJURY AS THE STENT HAD TO BE REMOVED IN MULTIPLE PIECES FOLLOWING STENT FRACTURE (PRECEDENCE). STENT DISINTEGRATED. "AS PER COMPLAINT FORM": DURING A CONTROLLING, THE PHYSICIAN FIND A DISINTEGRATED STENT, IN THE ORIGINAL POSITION. WE EXPLANT THE STENT IN 20 PARTS AND IMPLANT A NEW ONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7821682 ↗
• MalfunctionJul 16, 2018Difficult to Advance; Difficult to Advance

  REPORT IS BEING SUBMITTED UNDER THE PRECEDENCE OF ¿FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED'. ENDOSCOPIC DUODENAL STENT PLACEMENT WAS CONDUCTED ON A FEMALE PATIENT. THE DELIVERY SYSTEM OF THE DEVICE WAS UNABLE TO ADVANCE OVER ANOTHER MANUFACTURER'S WIRE GUIDE DUE TO SEVERE PYLORIC STENOSIS AND SEVERE TORTUOSITY FROM THE DUODENUM BULB TO THE DESCENDING PART OF THE DUODENUM, AND ALSO A KINK WAS CONFIRMED IN THE SHEATH. THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT, THEN BALLOON DILATION WAS PERFORMED TO FINISH THE PROCEDURE. THE PATIENT HAD A FAVOURABLE OUTCOME.

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

  MAUDE report 7689893 ↗
• MalfunctionMay 1, 2018Fracture; Kinked; Fracture; Kinked

  OPERATOR FELT DIFFICULTY WHILE ADVANCING WIRE GUIDE AND THE HANDLE CANNOT BE TRIGGERED DURING THE SENT RELEASE STAGE. OPERATOR FOUND OUT THE JOINT OF OUTER SHEATH AND HANDLE IS KINK. TO REPLACE ANOTHER SAME PRODUCT TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7475217 ↗