CONMED 000150Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10653405050858), received between May 10, 2016 and Mar 6, 2023 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Bent” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 000150, MARKED GUIDEWIRE (2/CS), WAS BEING USED DURING AN EGD DILATION PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿DISTAL SPRING TIP KINK AFTER THEY WERE PULLED OUT OF AN ENDOSCOPE FOR A DILATION PROCEDURES THAT WERE PERFORMED.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE CAUSING A 10-MINUTE DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484575 ↗
• MalfunctionMar 6, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 000150, MARKED GUIDEWIRE (2/CS), WAS BEING USED DURING AN EGD DILATION PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿DISTAL SPRING TIP KINK AFTER THEY WERE PULLED OUT OF AN ENDOSCOPE FOR A DILATION PROCEDURES THAT WERE PERFORMED.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE CAUSING A 10-MINUTE DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484574 ↗
• MalfunctionDec 16, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 000150, MARKED GUIDEWIRE (2/CS), WAS BEING USED DURING AN ESOPHAGEAL WIRE GUIDED DILATION PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿FACILITY STATED WIRE WAS PUT DOWN AS USUAL, SAVARY DILATOR WAS PLACED OVER WIRE AS THEY ALWAYS DO, DILATION WAS DONE, AND WHEN THEY WENT TO PULL IT ALL OUT, THE TIP OF THE WIRE FELL OFF, THEY HAD TO USE FORCEPS TO RETRIEVE IT FROM THE PATIENT, NO PATIENT INJURY¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS PLANNED WITH A FEW MINUTES DELAY TO RETRIEVE THE TIP OF THE DEVICE. THE PATIENT IS LISTED AS ¿FINE¿. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15994794 ↗
• MalfunctionSep 1, 2021Material Fragmentation; Material Fragmentation

  ON BEHALF OF THE FACILITY, THE CONMED REPRESENTATIVE REPORTED ISSUES WITH THE 000150, SPRING TIP MARKED GUIDEWIRE, LOT 202101134, THAT DIGESTIVE ENDOSCOPY CENTER RECENTLY EXPERIENCED ON (B)(6) 2021. THE INFORMATION RECEIVED THAT AFTER SAVORY DILATION, THE SPRING BROKE LOOSE FROM THE GUIDE WIRE AND FELL INTO THE GASTRIC POUCH. SPRING WAS RETRIEVED USING A SNARE RESULTING IN NO COMPLICATIONS. IT WAS THE FIRST TIME USE OF THE GUIDE WIRE. IT IS NOTED THERE WAS NO IMPACT OR INJURY TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATES AN ESOPHAGEAL DILATION WAS BEING PERFORMED WHEN THE SPRING BROKE FROM THE GUIDEWIRE. THIS WAS THE FIRST TIME THE FACILITY OPENED THE PACKAGE AND USED THE PRODUCT. IT IS UNKNOWN WHAT DILATOR WAS BEING UTILIZED IN THIS PROCEDURE. THERE WAS NOTHING UNUSUAL OR CONCERNING ABOUT THE SPRING TIP GUIDEWIRE PRIOR TO ITS USE. ADDITIONAL INFORMATION RECEIVED VIA SUS VOLUNTARY EVENT REPORT # MW5101802. IT IS NOTED THE EVENT WAS (B)(6) (NOT (B)(6)). THE DOCTOR WAS USING THE 000150, WHEN REMOVED, STAFF NOTICED THE TIP HAD BROKEN OFF IN THE PATIENT. ANOTHER SCOPE WAS INSERTED AND THE FOREIGN BODY WAS REMOVED. COMMUNICATION W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411164 ↗
• MalfunctionMar 26, 2020Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5092972) RECEIVED FROM THE FDA ON (B)(6) 2020. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE DURING THIS TIMEFRAME. THE 000150, MARKED GUIDEWIRE, DEVICE WAS REPORTED AS BEING USED DURING AN EGD PROCEDURE ON (B)(6) 2020 WHEN THE REUSABLE GUIDEWIRE SPRING TIP BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN REMOVED THE GUIDEWIRE FROM THE SCOPE AND PROCEEDED TO INSERT A SNARE TO RETRIEVE THE WIRE SPRING. THE COMPONENTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED DELAY. THE PATIENT IS REPORTED AS HAVING NOT SUSTAINED ANY INJURY AND DENIED ANY PROBLEMS DURING THE FOLLOW UP CALL THE FOLLOWING BUSINESS DAY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9883743 ↗
• MalfunctionMay 30, 2019Material Twisted/Bent; Material Twisted/Bent

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE, 000150, DEVICE BENT DURING A DILATION WITH SAVARY DILATORS PROCEDURE ON (B)(6) 2019. THE FACILITY REPORTED, "WHILE IN USE, GUIDEWIRE BENT AT THE END AND COULD HAVE POTENTIALLY PERFORATED THE PATIENT'S ESOPHAGUS." THERE WAS NO REPORT OF PATIENT OR USER INJURY, NO MEDICAL INTERVENTION REQUIRED AND NO HOSPITALIZATION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8653486 ↗
• MalfunctionMar 22, 2018Break; Break

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE, THE 000150 GUIDEWIRE SPRING TIP BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE GUIDEWIRE. THE PATIENT DID NOT REQUIRE ADDITIONAL TREATMENT DUE TO THIS INCIDENT AND NO INJURY WAS REPORTED. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION THAT MAY HAVE CONTRIBUTED TO AN INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7363775 ↗
• MalfunctionFeb 20, 2018Break; Break

  THE USER FACILITY REPORTED AFTER COMPLETION OF AN EGD WITH DILATION USING A 000150 GUIDEWIRE, THE TIP WAS OBSERVED TO BE DETACHED. USING AN EGD SCOPE AND SNARE, THE SURGEON REMOVED THE DETACHED TIP FROM THE PATIENT. THIS DEVICE MALFUNCTION CAUSED A 15-MINUTE SURGICAL DELAY AND DID NOT CAUSE HARM TO THE PATIENT OR USER. ADDITIONAL INFORMATION WITH REGARDS TO THE NUMBER OF PROCEDURES THIS DEVICE HAS BEEN USED IN IS NOT AVAILABLE. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED DEVICE MALFUNCTION WITH POTENTIAL FOR PATIENT INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7283339 ↗
• InjuryOct 20, 2017Bent; Bent

  THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT AFTER AN EGD PROCEDURE THE MARKED GUIDEWIRE WAS BENT AND HAD BLOOD AT THE TIP. A SCOPE WAS USED TO ASSESS THE ESOPHAGUS AND TRAUMA ON THE ESOPHAGEAL WALL WAS FOUND. A CLIP WAS APPLIED TO THE TEAR TO REGAIN HEMOSTASIS. THE PROCEDURE WAS COMPLETED WITH A 5-MINUTE SURGICAL DELAY. THE PATIENTS' POST-OP APPOINTMENT WENT WELL AND HE IS RECOVERING AS EXPECTED. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED PATIENT INJURY.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 6966674 ↗
• MalfunctionOct 20, 2017Bent; Bent

  THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT AT THE END OF AN EGD PROCEDURE, THE MARKED GUIDEWIRE WAS OBSERVED TO BE BENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED SURGICAL DELAYS OR PATIENT INJURY. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6964872 ↗
• InjuryAug 24, 2017Bent; Bent

  A PHYSICIAN WAS PERFORMING AN ESOPHAGEAL DILATION WITH THE ASSISTANCE OF A MARKED GUIDEWIRE. THE PROCEDURE OF ESOPHAGEAL DILATION STARTED WITH A 27 SAVARY FRENCH DILATOR, THEN DILATED UP TO SIZE 57 FRENCH DILATOR WITHOUT MAJOR RESISTANCE OR COMPLICATION. THE PATIENT WAS THEN ADVANCED TO A SIZE 60 FRENCH AND DILATED WITHOUT RESISTANCE; HOWEVER ON REMOVAL OF THE GUIDEWIRE AND DILATOR, THERE WAS BLOOD ON THE DISTAL TIP OF THE DILATOR AND THE GUIDEWIRE TIP WAS BENT. RIGID ESOPHAGOSCOPY WAS PERFORMED TO EVALUATE THE ESOPHAGUS. PATIENT HAD A MILD TEAR OF THE POSTERIOR MUCOSA ESOPHAGEAL WALL. THERE WAS NO TEAR/PENETRATION THROUGH THE UNDERLYING MUSCLE. NO FURTHER INTERVENTIONS WERE NEEDED. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED PATIENT INJURY.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 6818621 ↗
• MalfunctionFeb 27, 2017Bent; Bent

  THE USER FACILITY REPORTED THAT WHILE USING THE CONMED MARKED SPRING TIP GUIDEWIRE DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) ON (B)(6) 2017, "THE DOCTOR DID A STANDARD 54 FR DILATION ON THE PATIENT, UNDER NORMAL CONDITIONS. THE WIRE WAS BRAND NEW OUT OF THE PACKAGE AND PASSED DOWN THE SCOPE, WHICH WAS RELATIVELY STRAIGHT, BUT WHEN THE WIRE WAS REMOVED AFTER DILATION, IT WAS BENT TO THE POINT WHERE IT COULDN'T BE USED." THERE WAS NO PATIENT OR USER INJURY WITH THIS REPORTED INCIDENT. TO DATE THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION THAT LONG TERM ADVERSE EFFECT HAS OCCURRED. THIS REPORT IS FILED ON THE BASIS OF POTENTIAL INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6360406 ↗
• MalfunctionMay 11, 2016Break; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT DURING USE OF A MARKED SPRING TIP GUIDEWIRE IN AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE ON (B)(6) 2016, THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT. AS REPORTED, THE TIP OF THE GUIDEWIRE WAS RETRIEVED WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS, SURGICAL DELAY OR PATIENT INJURY. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT LATEST CONDITION OR ANY INDICATION THAT A LONG TERM ADVERSE EFFECT HAS OCCURRED.

  Patient problems: No Code Available

  MAUDE report 5646354 ↗
• MalfunctionMay 10, 2016Break; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT DURING USE OF A MARKED SPRING TIP GUIDEWIRE IN AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE ON (B)(6) 2016, THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT. AS REPORTED, THE TIP OF THE GUIDEWIRE WAS RETRIEVED WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS, SURGICAL DELAY OR PATIENT INJURY. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT LATEST CONDITION OR ANY INDICATION THAT A LONG TERM ADVERSE EFFECT HAS OCCURRED.

  Patient problems: No Code Available

  MAUDE report 5644724 ↗