Fanelli G13699Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00827002136991), received between Dec 23, 2016 and Jul 13, 2022 — classified as 8 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2022Break; Break

  IT WAS REPORTED THAT ON A ROUTINE CHECK, THREE FANELLI LAPAROSCOPIC ENDOBILIARY STENT SETS WERE FOUND TO BE BREAKING APART AT THE FLEXIBLE TIP. ALL PACKAGING WAS NOTED TO BE INTACT, UNDAMAGED AND WITHIN THE EXPIRATION DATE. NO PATIENT CONTACT WAS MADE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15005876 ↗
• MalfunctionAug 19, 2021Fracture; Nonstandard Device; Failure to Eject; Fracture; Nonstandard Device; Failure to Eject

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12341703 ↗
• MalfunctionJun 2, 2021Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922514 ↗
• MalfunctionApr 23, 2021Degraded; Material Fragmentation; Material Separation; Degraded; Material Fragmentation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716767 ↗
• MalfunctionDec 30, 2020Material Disintegration; Material Disintegration

  IN ADDITIONAL INFORMATION RECEIVED ON 13JAN2021, IT WAS REPORTED THAT THE DEVICES WERE NOT STORED IN DIRECT SUNLIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11094892 ↗
• InjuryNov 5, 2020Material Disintegration; Material Disintegration

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10793815 ↗
• MalfunctionOct 8, 2020Material Disintegration; Material Disintegration

  IT WAS REPORTED IN ADDITIONAL INFORMATION RECEIVED ON 08NOV2020 THAT THE DEVICE WAS STORED IN A STERILE STORE ROOM AREA AND NOT IN DIRECT LIGHT.

  Patient problems: No Patient Involvement

  MAUDE report 10648236 ↗
• MalfunctionJul 30, 2020Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 10344521 ↗
• MalfunctionJul 30, 2020Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 10344392 ↗
• MalfunctionJul 24, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 8822995 ↗
• MalfunctionMar 22, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8445552 ↗
• MalfunctionFeb 27, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8374009 ↗
• InjuryFeb 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT UNDERWENT A CHOLECYSTECTOMY VIA A LAPAROSCOPIC CHOLANGIOGRAPHY. DURING THE PROCEDURE, A FANELLI LAPAROSCOPIC ENDOBILIARY STENT SET WAS USED AS THE CHOLANGIOGRAM "SHOWED INITIALLY A VERY SMALL AMOUNT OF CONTRAST GETTING INTO THE DUODENUM THEN OBSTRUCTION WITH A VISIBLE STONE". UNDER FLUOROSCOPY, AFTER THE CYSTIC DUCT INTRODUCER WAS REMOVED, THE STENT AND THE STENT DELIVERY SYSTEM WERE PASSED OVER THE GUIDE WIRE INTO THE CYSTIC DUCT AND ADVANCED THROUGH THE AMPULLA AND PART WAY INTO THE DUODENUM. THE RADIOPAQUE MARKINGS OF THE STENT DELIVERY SYSTEM SHOWED 2 IN THE COMMON BILE DUCT AND 2 IN THE DUODENUM. WHEN THE OUTER SLEEVE OF THE DELIVERY SYSTEM WAS RETRACTED TO DEPLOY THE STENT, RESISTANCE WAS ENCOUNTERED WHEN PULLING THE PROXIMAL PORTION OF THE DELIVERY SYSTEM BACK WITH THE GUIDE WIRE. AS A RESULT, THE WIRE WAS REMOVED AND THE DELIVERY SYSTEM COULD BE PULLED BACK WITH LITTLE OR NO RESISTANCE [SIC]. AS THE RADIOPAQUE MARKERS ON THE END OF THE DEVICE APPROACHED THE POSITION OF FINAL DEPLOYMENT, RESISTANCE WAS MET AGAIN. RETRACTION WAS CONTINUED. THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, THE 2 RADIOPAQUE MARKERS CAME OFF THE DELIVERY SYSTEM AND FELL INT

  Patient problems: Foreign Body In Patient

  MAUDE report 8297974 ↗
• InjuryDec 13, 2018Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 04MAR2019. THE PROCEDURE WAS SUCCESSFUL AND A SECOND STENT WAS USED AND PERFORMED PROPERLY. ALSO, THE PATIENT IS IN GOOD STATUS WITH NO PROBLEMS POST OPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 8159548 ↗
• InjurySep 21, 2018Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION WAS PROVIDED FROM THE FACILITY. THE DEVICE WAS INTRODUCED INTO THE COMMON BILE DUCT, HOWEVER, THE DOCTOR WAS UNSURE IF PROPER PLACEMENT WAS ACHIEVED. THE DEVICE WAS WITHDRAWN BY PULLING BACK COMPLETELY AND PART OF THE STENT REMAINED IN THE PATIENT AND THE ANOTHER PART REMAINED WITHIN THE MECHANISM. THE PATIENT HAD A SCHEDULED ERCP; THEREFORE, THIS WAS NOT AN ADDITIONAL PROCEDURE NOR DID IT REQUIRE ONE. THE PATIENT CURRENTLY HAS SHOWN NO COMPLICATIONS AND FRAGMENTS ARE BEING SENT TO COOK MEDICAL FOR EVALUATION. THE DEVICE WAS NOT EXPOSED TO NATURAL LIGHT AND KEPT IN A STORAGE ROOM WITH STANDARD FLURO TUBE LIGHTING SYSTEMS.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7899023 ↗
• MalfunctionMay 7, 2018Fracture; Kinked; Fracture; Kinked

  IT WAS REPORTED A FANELLI LAPAROSCOPIC ENDOBILIARY STENT SET FRACTURED INTO A NUMBER OF SMALL PIECES BEFORE USE. THIS DEVICE WAS STORED IN A STOREROOM WITH FLUORESCENT LIGHT. THE DOCTOR DISCOVERED THIS DURING PRE-OP OF A LAPAROSCOPIC CHOLECYSTECTOMY AND USED ANOTHER DEVICE TO COMPLETE THE SCHEDULED PROCEDURE. AS REPORTED, THIS DEVICE MADE NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7489818 ↗
• InjuryMar 22, 2018Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT, WHEN THE TIP OF THE FANELLI LAPAROSCOPIC ENDOBILIARY STENT ENTERED THE CYSTIC DUCT, IT KINKED AND COULD NOT BE ADVANCED. THE OPERATOR PROCEEDED TO PULL THE DEPLOYMENT DEVICE BACK IN ORDER TO REMOVE THE PRODUCT ALTOGETHER, BUT THE STENT COVER CAME OFF OF THE DEVICE AND REMAINED IN THE PATIENT'S ABDOMEN. THE COMPONENT PART WAS THEN RETRIEVED WITH A MARYLAND DISSECTOR. THE PROCEDURE WAS ULTIMATELY COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE OF THE SAME TYPE. NO ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT OF THE PRODUCT PROBLEM, AND NO UNINTENDED SECTIONS OF THE DEVICE REMAINED IN THE PATIENT. THE COMPLAINT DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE DEVICE INVESTIGATION IS STILL PENDING.

  Patient problems: No Code Available

  MAUDE report 7363255 ↗
• MalfunctionJan 16, 2018Material Fragmentation; Material Fragmentation

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE PLASTIC FROM THE FANELLI LAPAROSCOPIC ENDOBILIARY STENT SET HAD CHIPPED OFF IN SEVERAL PLACES INSIDE THE STERILE PACKAGING OF THE PRODUCT. THIS WAS DISCOVERED PRIOR TO THE USE OF THE PRODUCT ON A PATIENT; ACCORDINGLY, NO PATIENT ADVERSE EVENTS RESULTED FROM THE PRODUCT ISSUE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 7197443 ↗
• InjuryNov 13, 2017Fracture; Fracture

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE FANELLI LAPAROSCOPIC ENDOBILIARY STENT WAS ADVANCED OVER THE WIRE INTO THE PATIENT AND WAS BEING INTRODUCED TO THE CYSTIC DUCT, THE SURGEON NOTICED A CRACK AT THE STENT PERFORATION WHICH WAS VISIBLE VIA THE LAPAROSCOPE WHICH WAS USED BY THE OPERATOR. AS THE STENT WAS BEING WITHDRAWN, THE FLANGE REPORTEDLY BROKE OFF INTO THE CYSTIC DUCT. WHEN THE SURGEON SUBSEQUENTLY REMOVED THE ENTIRE STENT AND THE INNER CATHETER, THE STENT WAS OBSERVED TO HAVE BROKEN INTO 4 DIFFERENT PIECES. THE SURGEON THEN SUCCESSFULLY RETRIEVED THE REMAINING FLANGE PIECE FROM THE CYSTIC DUCT VIA CYSTIC DUCT EXPLORATION AND INCREASED OPERATIVE TIME. A SECOND FANELLI STENT WAS ULTIMATELY EMPLOYED SUCCESSFULLY. NO FURTHER ISSUES WERE REPORTED. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 7026759 ↗
• MalfunctionJul 21, 2017Bent; Fracture; Bent; Fracture

  IT WAS REPORTED THAT A FANELLI LAPAROSCOPIC ENDOBILIARY STENT SET WAS OPENED AND TAKEN OFF THE DELIVERY SYSTEM. THE DEVICE WAS BENT AND IT FRACTURED ON THE TABLE PRIOR TO DELIVERY. THE EVENT OCCURRED PRIOR TO PATIENT CONTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6734662 ↗
• MalfunctionJul 21, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING PREPARATION FOR A LAPAROSCOPIC CHOLECYSTECTOMY, THE FANELLI LAPAROSCOPIC ENDOBILIARY STENT WAS OBSERVED TO BE FRAGMENTED. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6733394 ↗
• MalfunctionJun 22, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A FANELLI BILIARY STENT FOR AN UNSPECIFIED INDICATION. THE CUSTOMER REPORTS THAT THE DEVICE WAS SUCCESSFULLY PLACED WITHIN THE PATIENTS' COMMON BILE DUCT. THE PHYSICIAN STATES "I DEPLOYED THE STENT IN ACCORDANCE WITH MANUFACTURES INSTRUCTIONS AND THE METAL MARKERS ON THE STENT DEPLOYMENT SYSTEM CAME OFF AND ARE IN THE COMMON BILE DUCT." THE PHYSICIAN EXPECTED TO HAVE A GASTROENTEROLOGIST PERFORMED AN ERCP TO NOT ONLY CLEAR THE DUCT BUT TO RETRIEVE THE METAL PIECES. THE PHYSICIAN SUBSEQUENTLY REPORTED THAT THE METAL SEEN AFTER INITIAL DEPLOYMENT OF THE DEVICE WAS GONE AT THE TIME OF THE FOLLOW-UP ERCP AND OPINES THAT THE DEVICES 'APPARENTLY PASSED.' THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6659800 ↗
• InjuryJun 1, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A STENT PLACEMENT ON (B)(6) 2017 FOR AN UNSPECIFIED INDICATION. THE CUSTOMER REPORTED THAT TWO PIECES OF THE STENT WERE LEFT IN THE PATIENTS' COMMON BILE DUCT. THE PATIENT UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY (ERCP) AND FLUOROSCOPY AT AN UNSPECIFIED TIME FOLLOWING THE INITIAL PROCEDURE TO LOCATE THE FRAGMENTS. NO RETAINED FRAGMENTS WERE IDENTIFIED. THE CUSTOMER OPINES THAT THE FRAGMENTS HAVE CLEARED THE PATIENT'S BODY. NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 6604507 ↗
• MalfunctionMay 22, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT THE DEVICE WAS BEING EXAMINED PRIOR TO USE. A PIECE OF LOOSE PLASTIC WAS OBSERVED IN THE PACKAGE DURING THIS EXAMINATION. THE CUSTOMER INDICATED THAT THE DEVICE FRACTURED 2CM FROM THE TIP. THE PACKAGE WITH DEVICE WAS NOT USED AND EXCHANGED FOR ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT. THE DEVICE IS AVAILABLE FOR EXAMINATION, HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 6582348 ↗
• MalfunctionMay 3, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS SCHEDULED TO UNDERGO PLACEMENT OF A FANELLI LAPAROSCOPIC ENDOBILIARY STENT FOR AN UNSPECIFIED INDICATION. THE CUSTOMER STATED THAT TWO STENTS BROKE PRIOR TO PATIENT CONTACT. THE CIRCUMSTANCES AND HANDLING CONDITIONS AT THE TIME OF THE EVENT ARE NOT KNOWN. THERE WAS NO ADVERSE PATIENT CONSEQUENCE. THE DEVICES WERE DISCARDED AND NO LONGER AVAILABLE FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6540136 ↗