Zilver 635 G50623Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10827002506234), received between Feb 14, 2017 and Jan 9, 2026 — classified as 5 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Failure to Advance; Material Twisted/Bent

  USER OPENED THE PACKAGE AND INJECTED WATER, THEN ADVANCED THE DELIVERY SYSTEM THROUGH WIRE GUIDE WHILE FOUND OUT THE WIRE GUIDE CANNOT BE PUT THROUGH DELIVERY SYSTEM. USER RETRACTED THE DEVICE AND CHANGED TO A NEW ONE 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. CAN YOU PROVIDE THE TRACKING INFORMATION FOR THE RETURNED DEVICE? YES. WHAT ENDOSCOPE CHANNEL SIZE WAS USED? 4.2. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? YES. WHAT WAS THE TARGET LOCATION OF THE STENT? LEFT HEPATIC DUCT DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER)? ACRO-35-450. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? (IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE (E.G., CHOLODOCHOJEJUNOSTOMY)) NO. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM (E.G., KINKS) PRIOR TO RETURN? (IF YES, PLEASE SPECIFY WHAT ADDITIONAL DEFECT(S) WERE OBSERVED AND WHERE ON THE DEVICE THIS WAS OBSERVED)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016853 ↗
• MalfunctionJan 9, 2026Dent in Material; Activation Failure

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 04-FEB-26.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016833 ↗
• MalfunctionSep 30, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  NURSE OPENED THE PACKAGE AND FLUSH WITH WATER, THEN ADVANCED THE STENT DELIVERY SYSTEM THROUGH WIRE GUIDE AND ENDOSCOPE TO BILE DUCT DESIRED POSITION, DURING STENT RELEASING USER DETECTED THE STENT CANNOT BE DEPLOYED. USER RETRACTED THE STENT DELIVERY SYSTEM FROM ENDOSCOPE AND FOUND OUT THERE IS WIRE LIKE MATERIAL OUT OF FROM THE TIP OF DELIVERY SYSTEM. USER CHANGED TO A NEW DEVICE WITH SAME RPN 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 23178831 ↗
• InjuryDec 4, 2024Break; Fracture; Break; Fracture

  PATIENT WAS IMPLANTED WITH STENT ON (B)(6) 2024. ON (B)(6) 2024, DURING FOLLOW UP VISIT A CT SCAN WAS CONDUCT WHILE FOUND OUT THE STENT BROKEN INTO 2 PIECES AND MIGRATED. PATIENT REQUIRED TO REMOVE ONE BROKEN PIECE OF STENT. ONE BROKEN PIECE OUTSIDE OF DUODENAL PAPILLA WAS REMOVED THROUGH PAINLESS GASTROSCOPY, BUT ANOTHER PIECE CANNOT BE REMOVED. SALES REP. FROM DISTRIBUTOR HONEST MEDICAL REQUIRES COOK TO GIVE THE GUIDANCE FOR FOLLOW UP ACTION. USER FACILITY GIVE THE PIECE THAT REMOVED TO PATIENT KEEP. UPDATED ON 26NOV2024. USER FACILITY ((B)(6) HOSPITAL) REPORTED THE SAME CASE TO AUTHORITY AS AE AND COOK CHINA WAS NOTIFIED THE AE FROM NATIONAL AE SYSTEM ON 26NOV2024 AFTERNOON. BELOW IS THE DESCRIPTION TRANSLATION FROM THE REPORT THAT USER FACILITY SUBMITTED: HARM: MAY LEAD TO RECURRENCE OF OBSTRUCTION AND INCREASED RISK OF INFECTION DEVICE MALFUNCTION: STENT BROKEN THE PATIENT WAS ADMITTED TO OUR HOSPITAL FOR OBSTRUCTIVE JAUNDICE, AND AFTER COMPLETING THE PREOPERATIVE EXAMINATION, DUODENOSCOPY WAS PERFORMED UNDER GENERAL ANESTHESIA ON (B)(6) 2024 IN ORDER TO RELIEVE BILIARY OBSTRUCTION. THE OPERATION WAS TERMINATED DUE TO THE PATIENT'S POSTERIOR DUODENAL BULBOUS STENOSIS, AND THE

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

  MAUDE report 20843830 ↗
• MalfunctionSep 30, 2024Break; Activation Failure; Break; Activation Failure

  SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE COMPLETION OF THE INVESTIGATION ON 14-MAY-25 AS THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT. "NO ADVERSE EFFECT 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)¿ NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR." DEPLOYMENT FORCE IS TOO HIGH; USER CANNOT PULL BACK THE HANDLE TOWARDS THE HUB TO DEPLOY THE STENT. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. LOW RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334063 ↗
• MalfunctionJul 16, 2024Premature Activation; Premature Activation

  DESCRIPTION OF EVENT: USER SUCCESSFULLY EXCHANGED TO HILUM HEPATIS LEFT AND RIGHT HEPATIC DUCT, THEN TOOK SBDC-8.5 TO DILATE THE STRICTURE AREA. THEN ADVANCED 2 STENT OF ZILBS-635-8-8 TO CORRESPONDINGLY LEFT AND RIGHT HEPATIC DUCT(EACH DUCT WAS ATTEMPTED TO PLACE ONE STENT) USER ADVANCED THE STENT THROUGH STRICTURE AREA IN LEFT HEPATIC DUCT SUCCESSFULLY, BUT USER CANNOT ADVANCED THE STENT THROUGH STRICTURE AREA OF RIGHT HEPATIC DUCT, USER THEN AGAIN TO ADVANCED THE DELIVERY SYSTEM WHILE ENCOUNTERED RESISTANCE, USER RETRACTED THE STENT FROM RIGHT HEPATIC DUCT AND DETECTED THERE IS 1 CM LONG STENT WAS PREMATURE DEPLOYED. USER THEN CHANGED TO A NEW ZILBS-635-8-8 STENT AND SUCCESSFULLY DEPLOYED IN BOTH HEPATIC DUCT, AND THE PROCEDURE WAS COMPLETED. 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: UPDATED ON 9JUL2024 TP 1. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? DISTRIBUTOR NEED TO COMMUNICATE WITH USER FACILITY TO OBAINT THE IMAG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749303 ↗
• MalfunctionJun 18, 2024Break; Fracture; Break; Fracture

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 12-SEP-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556307 ↗
• MalfunctionMar 12, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  THEY WERE UNABLE TO DEPLOY THE ZILVER 635 8X8 STENT. THEY WERE ATTEMPTING TO PLACE 2 STENTS BILATERAL BUT WERE ABLE TO ONLY DEPLOY ONE OF THE 2. THE PATIENT WAS NOT HARMED. PATIENT OUTCOME: PER EMAIL ON 14FEB2024: THE PATIENT WAS NOT HARMED. 15FEB2024 PATIENT/EVENT INFO - NOTES: THE FOLLOWING INFORMATION HAS BEEN REQUESTED AND RECEIVED VIA EMAIL ON 15FEB2024. 1. WHAT WAS THE DATE OF THE OCCURRENCE? (B)(6): 2. ON WHAT DATE WERE YOU NOTIFIED? FEBRUARY 13TH 3. WILL THE FACILITY BE REPORTING THIS TO A GOVERNMENT AGENCY (FDA, COMPETENT AUTHORITY, ETC.) NO 4. USAGE OF PRODUCT (PLEASE SELECT ONLY ONE BELOW): 1. INITIAL USE OF DEVICE: YES 5. WAS PRODUCT REPROCESSED FOR REUSE PRIOR TO OCCURRENCE? NO 6. CAN YOU PROVIDE ANY PATIENT INFORMATION (AGE, WEIGHT, GENDER, PRE-EXISTING CONDITIONS)? NO 7. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO 8. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? INSERTION 9. WAS A SPHINCTEROTOMY PERFORMED PRIOR TO USE OF THE STENT DEVICE? UNKNOWN 10. WAS BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT DEVICE? UNKNOWN 11. WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? UNKNOWN 12. WHAT BRAND OF ENDOSCOPE WAS USED WITH THE DEVICE? OLYMPUS 13.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884481 ↗
• MalfunctionJul 28, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 31-JAN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412337 ↗
• MalfunctionJul 21, 2023Break; Break

  THE STENT DID NOT RELEASE AND WHEN IT WAS REMOVED, THE CATHETER WAS UNSHEATHED (SEE PHOTO). A DIFFERENT SIZE STENT WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. AN ANOTHER ZILVER WAS USE. NO PROBLEM ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. 1. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES. 2. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? DURING STENT PLACEMENT. 3. WAS A SPHINCTEROTOMY PERFORMED PRIOR TO USE OF THE STENT DEVICE? YES. 4. WAS BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT DEVICE? NO. 5. WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? NA. 6. WHAT BRAND OF ENDOSCOPE WAS USED WITH THE DEVICE? PENTAX . 7. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? YES. 8. WHAT WAS THE POSITION OF THE ELEVATOR DURING DEPLOYMENT? OPEN. 9. WAS THE DELIVERY SYSTEM TRACKED AROUND A TIGHT ANGLE IN THE PATIENT ANATOMY OR AROUND A TIGHT ANGLE IN AN ENDOSCOPE? NO. 10. WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? YES. 11. DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370380 ↗
• MalfunctionJul 5, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  UPON DEPLOYING BILATERAL STENT, THE DEPLOYMENT DEVICE BROKE WITHIN THE SCOPE (395986 )-. THE PROCEDURE WAS COMPLETED BY REMOVING THE DEVICE FROM THE SCOPE WITH A BIOPSY FORCEP. THE STENT WAS ABLE TO BE PLACED IN THE TARGET LOCATION. NO HARM TO PATIENT AND NO NEED FOR ADDITIONAL/INTERVENTIONAL PROCEDURES. THIS FILE WILL CAPTURE THE USER ERROR OF NOT DEPLOYING THE SIDE-BY-SIDE STENTS SIMULTANEOUSLY AS PER IFU. 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 17257308 ↗
• MalfunctionMay 26, 2023Break; Improper or Incorrect Procedure or Method; Material Twisted/Bent; Break; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  UPON DEPLOYING BILATERAL STENT, THE DEPLOYMENT DEVICE BROKE WITHIN THE SCOPE. THE PROCEDURE WAS COMPLETED BY REMOVING THE DEVICE FROM THE SCOPE WITH A BIOPSY FORCEPS. THE STENT WAS ABLE TO BE PLACED IN THE TARGET LOCATION. NO HARM TO PATIENT AND NO NEED FOR ADDITIONAL/INTERVENTIONAL PROCEDURES. PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO 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? NA PATIENT/EVENT INFO - NOTES: 3.2.13 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO - YES XRAY IMAGE OF STENT PLACEMENT 3.2.14 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? REMOVING THE INTRODUCER POST STENT PLACEMENT 3.2.15 WAS A SPHINCTEROTOMY PERFORMED PRIOR TO USE OF THE STENT DEVICE? N/A, YES, NO - YES 3.2.16 WAS BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17008903 ↗
• InjuryApr 7, 2023Break; Dent in Material; Activation Failure; Break; Dent in Material; Activation Failure

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE LAB EVALUATION ON THE (B)(6) 2023 AND THE UPDATED COMPLETION OF THE INVESTIGATION ON THE (B)(6) 2023.

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

  MAUDE report 16699787 ↗
• InjurySep 7, 2022Premature Activation; Activation, Positioning or Separation Problem; Premature Activation; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATION VIA PHONE CONVERSATION THE DEVICE STARTED TO DEPLOY AS THE DEVICE WAS BEING PASSED DOWN THE ENDOSCOPY SCOPE. A NEW G50623-ZILBS-635-8-8 WAS OPENED AND USED TO COMPLETE THE INTENDED PROCEDURE. 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 DUE TO THIS OCCURRENCE? 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. 3.2.13 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? - ONE IMAGE IS BEING PROVIDED 3.2.14 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? UNPACKING OR PREPARATION, INSERTION, DURING STENT PLACEMENT, REMOVING THE INTRODUCER POST STENT PLACEMENT - DURING INSERTION. 3.2.15 WAS A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369578 ↗
• MalfunctionMay 10, 2022Failure to Advance; Failure to Advance

  COOK'S WIRE GUIDE AWG2-35-450-A/ W4308505 COULD PASS THROUGH THE STENOSED LESION IN THE HEPATIC PORTAL REGION THOUGH, THE ZILBS- DEVICE COULD NOT. THEREFORE, ANOTHER MANUFACTURER'S DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. PHYSICIAN'S COMMENT: THE LESION WAS SEVERELY STENOSED. ADDITIONAL INFORMATION. GENERAL QUESTIONS FOR ALL COMPLAINTS . (IF ANY DAMAGES WERE CONFIRMED PRIOR TO USE)WAS THE PACKAGE DAMAGED? NO. (IF ANY DAMAGES WERE CONFIRMED PRIOR TO USE)HOW WAS THE DEVICE STORED? WAS A SPHINCTEROTOMY OR BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT DEVICE? NO. WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? NO. WHAT BRAND OF ENDOSCOPE WAS USED WITH THE DEVICE? UNKNOWN. WHAT WAS THE TARGET LOCATION FOR THE COMPLAINT DEVICE? ALREADY STATED IN PATIENT/EVENT INFO TAB. WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? YES. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? ALREADY STATED IN PATIENT/EVENT INFO TAB. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE OR DELIVERY SYSTEM TO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14346521 ↗
• MalfunctionFeb 4, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  USER ERROR AS IT KNOWN FROM THE AVAILABLE INFORMATION THAT: THE USER DISCOVERED THAT THE STENT WAS PREMATURELY RELEASED, AND CUT THE RELEASED STENT IN ORDER TO USE THE DEVICE. THE USER TRIED TO USE A DAMAGED DEVICE ON THE PATIENT. "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." WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? ACRO-35-450. 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 ENDOSCOPE) ALSO ASK:. HAD A SPHINCTEROTOMY BEEN PERFORMED PRIOR TO THIS OCCURRENCE? YES. HAD DILATION OF THE OBSTRUCTED AREA BEEN PERFORMED PRIOR TO THIS OCCURRENCE? YES. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? OLYMPUS TF-260V. PLEASE DESCRIBE THE LOCATION IN THE BODY WHERE THE STENT WAS TO BE PLACED. COMMON BILE DUCT. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE THROUGH THE OBSTRUCTED AREA? YES. WAS RESISTANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13450997 ↗
• MalfunctionOct 22, 2021Premature Activation; Device Damaged Prior to Use; Premature Activation; Device Damaged Prior to Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO DEVICE EVALUATION ON 10-DEC-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12680194 ↗
• MalfunctionSep 22, 2021Break; Break

  AS PER REP'S EMAIL RECEIVED ON 31/8/21, HE CONFIRMED THAT THE COMPLAINT DEVICE IS A G50623 FROM LOT NUMBER C1719104. AS PER COMPLAINT FORM, COMPLAINT DEVICE COULD POSSIBLY BE G50623, TO BE CONFIRMED. THE REP HAS JUST BEEN INFORMED OF A BROKEN SILVER 635 STENT AT ST GEORGE PUBLIC HOSPITAL. NO KEY DETAILS AT THIS STAGE. TRYING TO ENGAGE THE DEPT, BUT HAVE BEEN ADVISED IT IS HECTIC AT THE MOMENT, PRODUCT CODE COULD BE G50623 / G50620 OR G23813 LOT NUMBER TO BE ADVISED ALONG WITH MANY OTHER DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12513725 ↗
• MalfunctionJun 16, 2021Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009986 ↗
• MalfunctionMar 5, 2021Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE COMPLAINT DEVICE BEING EVALUATED IN THE LAB AT CIRL ON (B)(6) 2021. COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 08FEB2021--DID 08FEB2021. AS REPORTED TO CUSTOMER RELATIONS: "DESCRIBE THE EVENT OR PROBLEM: INCIDENT DESCRIPTION: I DEPLOYED THE STENT INTO THE BILE DUCT, AND THE STENT NEVER DEPLOYED. IT WAS DAMAGED. FROM THE PROCEDURAL REPORT: 'NEXT, THE GUIDEWIRE WAS ADVANCED IN TO THE RT HEPATIC DUCT; THIS WIRE WAS LEFT IN PLACE. A SECOND 0.025IN VISGLIDE WIRE WAS PASSED AND WITH SOME DIFFICULTY WAS ADVANCED INTO THE LEFT HEPATIC DUCT. A ZILVER 8MM X 80MM UNCOVERED METAL STENT WAS ADVANCED OVER THE WIRE IN THE RIGHT SYSTEM WHILE A ZILVER 8MM X 80MM STENT WAS ADVANCED OVER THE WIRE IN THE LEFT SYSTEM. THE STENTS WERE POSITIONED APPROPRIATELY AND DEPLOYED SIMULTANEOUSLY UNDER FLUOROSCOPIC SUPPORT. ADEQUATE POSITIONING WAS NOTED WITH RESPECT TO BOTH STENTS. THE DISTAL ASPECT OF THE STENTS EXTENDED JUST BELOW THE DISTAL MARGIN OF THE COMMON DUCT STRICTURE. GOOD DRAINAGE OF CONTRAST WAS NOTED. THE PROCEDURE WAS COMPLETE. I PERSONALLY INTERPRETED ALL FLUOROSCOPIC IMAGES.' SUCCESSFUL BILIARY STENT REMOVAL. SUCCESSFUL PLACEMENT OF 8MM X 80

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419503 ↗
• MalfunctionOct 22, 2020Off-Label Use; Off-Label Use

  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 10721864 ↗
• MalfunctionFeb 6, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE STENT DID NOT DEPLOY. THE PROXIMAL END OF THE STENT WAS DEVIATED AND BROKE THE SHEET. "AS PER COMPLAINT FORM": KLATSKIN TUMER TYPE IV, DR. COULD INTRODUCE ONE WIRE GUIDE IN EACH HEPATIC DUCT, TWO ZILVER WERE INTRODUCED (AS WRITTEN IN IFU) AND AT THE TIME OF DEPLOYMENT ONE OF THE ZILVER DIDN'T DEPLOY AND THEY HAVE TO PULL IT OUT, LOOSING THE POSSIBILITY TO DRAIN THAT HEPATIC DUCT. PRODUCT SHOWS ONE OF THE GOLD CROWN OF THE STENT ITSELF WENT THROUGH THE COIL SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9675249 ↗
• MalfunctionFeb 5, 2020Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  THE STENT DID NOT DEPLOY THE PROXIMAL END OF THE STENT WAS DEVIATED AND BROKE THE SHEET. "AS PER COMPLAINT FORM": KLATSKIN TUMER TYPE IV, DR. COULD INTRODUCE ONE WIRE GUIDE IN EACH HEPATIC DUCT, TWO ZILVER WERE INTRODUCED (AS WRITTEN IN IFU) AND AT THE TIME OF DEPLOYMENT ONE OF THE ZILVER DIDN'T DEPLOY AND THEY HAVE TO PULL IT OUT, LOOSING THE POSSIBILITY TO DRAIN THAT HEPATIC DUCT. PRODUCT SHOWS ONE OF THE GOLD CROWN OF THE STENT ITSELF WENT THROUGH THE COIL SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9671253 ↗
• MalfunctionDec 19, 2019Material Twisted/Bent; Material Twisted/Bent

  THE DOCTOR TRIED TO INSERT A METAL STENT TO THE CBD. BECAUSE HARD STRICTURE HE CHOOSE THE ZILBS-635-8-8. BUT IT WAS FAILED, COULD NOT PASS. STRICTURE OF DUCT WAS SEVERE. HE TOOK OUT THE ZILBS-635 AND INSERTED THE PLASTIC STENT (CLSO-7-10).

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

  MAUDE report 9495632 ↗
• MalfunctionNov 8, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FOUND OUT THE PUSHER DETACHED FROM SHEATH DURING STENT DEPLOYMENT WHICH CASE STENT CANNOT BE RELEASED. THE USER CANCELLED THE OPERATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9294757 ↗