CleanGuide DIS150Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10653405986553), received between Feb 14, 2022 and Aug 11, 2026 — classified as 5 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (15 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Material Fragmentation

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

  MAUDE report 50206966 ↗
• MalfunctionFeb 12, 2026Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDSUN REPORT (B)(4) ON 23JAN26. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE,1.86 MM X 210 CM, DEVICE. IT WAS STATED THAT THE DEVICE WAS BEING USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE IN (B)(6) 2025, DAY UNKNOWN. THE REPORT STATED, ¿DURING THE EGD [ESOPHAGOGASTRODUODENOSCOPY] PROCEDURE, THE SPRING GUIDEWIRE PORTION WAS ADVANCED INTO THE PATIENT'S ESOPHAGUS THROUGH THE GIF [GASTROINTESTINAL FIBER-OPTIC] SCOPE. ONCE THE WIRE WAS IN PLACE THE SCOPE WAS RETRACKED OUT AND THE WIRE WAS LEFT IN DESIRED PLACE. THE BLUE TIP OF THE GUIDEWIRE WAS INSERTED INTO THE SAVORY DISTAL TIP WHILE THE GUIDEWIRE WAS HELD IN PLACE. DR. [REDACTED] INSTRUCTED [REDACTED], THE TECH, TO PULL GUIDEWIRE AS HE WAS ADVANCING THE SAVORY INTO THE PATIENT'S ESOPHAGUS. [REDACTED] INFORMED DR. [REDACTED] THAT HE FELT TENSION WHEN PULLING ON THE GUIDEWIRE UNTIL THE WIRE BECOMES LOOSE. ONCE THE WIRE WAS REMOVED [REDACTED] CONTINUED TO INSERT THE SAVORY AND COMPLETE THE DILATION. AFTER REMOVING THE SAVORY, DR. [REDACTED] R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321313 ↗
• MalfunctionMay 30, 2025Material Twisted/Bent; Material Twisted/Bent

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDSUN REPORT ((B)(4)) RECEIVED ON 19MAY25. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE,1.86 MM X 210 CM. THIS WAS REPORTED AS A PRODUCT PROBLEM NOT AN ADVERSE EVENT. THE REPORT STATES THAT IN (B)(6) 2025, THE DEVICE WAS USED IN AN ESOPHAGOGASTRODUODENOSCOPY WITH BIOPSY, SINGLE OR MULTIPLE PROCEDURE, AND ¿THE WIRE DEVICE ITSELF WAS BROKEN AT ABOUT AN 80- OR 90-DEGREE ANGLE FROM NORMAL". FURTHER ASSESSMENT FOUND THAT "BROKEN" MEANT THE DEVICE WAS BENT. THE DEVICE DID NOT FRAGMENT OR FALL INTO THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED AS NORMAL, WITHOUT THE USE OF AN ALTERNATE DEVICE AND WITH NO DELAY. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. 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 22114248 ↗
• MalfunctionMay 28, 2025Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE,1.86 MM X 210 CM DEVICE WAS USED IN A RIGID ESOPHAGEAL DILATION PROCEDURE ON (B)(6) 2025, AND ¿DIS150 WAS BROKEN AT THE TIP OF THE GUIDEWIRE WHERE THE SPRING TIP STARTS¿. THE PROCEDURE WAS COMPLETED AS NORMAL WITH THE USE OF AN ALTERNATE SAME DEVICE. FURTHER ASSESSMENT FOUND ¿THE TIP WAS BENT ¿OFF¿ WHERE THE SPRING TIP CONNECTS¿; "THE DEVICE WAS FRAGMENTED"; "NOTHING FELL INTO THE PATIENT AS THEY NOTICED THE PRODUCT PROBLEMS PRIOR TO THE PROCEDURE DURING SETTING UP FOR THE PROCEDURE¿. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT OR USER. 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 22097919 ↗
• MalfunctionMay 19, 2025Break

  THE WIRE DEVICE ITSELF WAS BROKEN AT ABOUT AN 80 OR 90 DEGREE ANGLE FROM NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043362 ↗
• MalfunctionFeb 10, 2025Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE,1.86 MM X 210 CM DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6)2025 AND, ¿UPON REMOVAL OF THE GUIDEWIRE FROM THE SAVORY DILATOR AFTER THE PROCEDURE THE SPRING TIP OF THE GUIDEWIRE BROKE OFF¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND WITH NO DELAY. FURTHER ASSESSMENT CONFIRMED NO DEVICE FRAGMENTS OR COMPONENTS FELL INTO THE SURGICAL SITE, AND THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT OR USER. 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 21344894 ↗
• MalfunctionMay 21, 2024Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE DEVICE WAS BEING USED DURING AN EGD PROCEDURE ON 08MAY24, AND ¿DISPOSABLE GUIDEWIRE BROKE DURING PROCEDURE IN PATIENT'S STOMACH DURING DILATION WITH A SAVORY DILATOR¿. FURTHER ASSESSMENT FOUND THAT THE DEVICE FRAGMENTED INTO THE SURGICAL SITE, AND ALL FRAGMENTS WERE "RETRIEVED USING A RETRIEVAL NET. NO INJURIES REPORTED. NO SURGICAL INTERVENTION NEEDED. PATIENT WAS UNHARMED. PATIENT LEFT SAME DAY. 10 MINUTE DELAY DURING PROCEDURE". THE PATIENT'S CURRENT STATUS IS "ALIVE". THE PROCEDURE WAS COMPLETED WITH ANOTHER DIS150 DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 19365469 ↗
• InjuryMar 18, 2024Material Twisted/Bent; Material Twisted/Bent

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE DEVICE WAS BEING USED DURING AN ESOPHAGEAL DILATION ON (B)(6) 2024, AND THE ¿WIRE KINKED IN 2 PLACES AFTER PLACED IN PATIENT. SAVARY DILATOR BECAME STUCK IN PATIENT.¿. FOLLOW-UP ASSESSMENT FOUND THAT THE "SAVARY DILATOR" WAS REMOVED FROM THE PATIENT INTACT. "AN OVERTUBE WAS PLACED FOR THE PATIENT'S SAFETY, AND SOMEHOW DR. WAS ABLE TO DISLODGE THE DEVICE WITH SLIGHT, CAREFUL MOVEMENTS. THE PATIENT HAD DEEP MUCOSAL TEARS/PUNCTURES FROM THE WIRE AND/OR SAVARY IN THE STOMACH AND ESOPHAGUS, WHICH NEEDED 6 CLIPS FOR CLOSURE. THE OUTPATIENT WAS CLOSELY MONITORED IN OUR RECOVERY AREA, BUT TO MY KNOWLEDGE DID NOT REQUIRE FURTHER MEDICAL ATTENTION. SHE HAD NO C/O PAIN ONCE SHE WOKE UP. SHE WAS DISCHARGED HOME. DR. RECOMMENDED A BARIUM SWALLOW AND A REPEAT EGD FOR FOLLOW UP." THE PROCEDURE WAS COMPLETED WITH A DELAY OF 10 MINUTES AND WITHOUT THE USE OF AN ALTERNATE SAME DEVICE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE REPORT OF DEEP MUCOSAL TEARS/PUNCTURES.

  Patient problems: Laceration(s); Laceration(s) of Esophagus

  MAUDE report 18924400 ↗
• MalfunctionJan 8, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE WAS BEING USED ON (B)(6) 2023 AND THE ¿SPRING TIP IN THE GUIDE WIRE BROKE OFF WHILE IN A PATIENT'S STOMACH. THE GUIDEWIRE WAS REMOVED AND THE BROKEN OF TIP WAS RETREIVED AND REMOVED WITH A SNARE.¿. THE PROCEDURE WAS COMPLETED WITH ¿ANOTHER WIRE¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR THE USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18463097 ↗
• MalfunctionDec 1, 2023Fracture; Fracture

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE, WAS BEING TESTED PRIOR TO A PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿GUIDEWIRE BROKE.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE CAUSING A 2-MINUTE DELAY IN THE PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245174 ↗
• MalfunctionNov 29, 2023Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF HER CUSTOMER THAT THE DEVICE, DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE, WAS BEING USED DURING AN EGD WITH DILATION PROCEDURE ON (B)(6) 2023 WHEN THE ¿SPRING TIP BROKE OFF DURING A CASE DURING INTRA-OP¿. FURTHER ASSESSMENT REVEALED THAT "IT FELL INTO THE STOMACH, WHERE THE SPRING TIP USUALLY GOES", AND THE "ITEM WAS RETRIEVED WITH A RETRIEVAL NET". THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN ALTERNATE LIKE DEVICE, AND THERE WAS A DELAY OF TWO MINUTES. THERE WAS NO REPORTED INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230785 ↗
• MalfunctionSep 12, 2023Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF MEDWATCH REPORT NO. MW5120455, IN WHICH A CUSTOMER REPORTED THAT THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE, WAS BEING USED ON 21JUL2023 AND ¿DURING EGD PROCEDURE GUIDEWIRE SPRING TIP BROKE OFF DURING INSERTION, TIP REQUIRED RETRIEVAL, NEW GUIDEWIRE USED TO COMPLETE PROCEDURE. NO INJURY TO PATIENT NOTED¿. THERE WAS NO REPORT OF DELAY, INJURY, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION FOR THE PATIENT. 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 17732082 ↗
• MalfunctionJul 26, 2023Material Twisted/Bent; Material Twisted/Bent

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DIS150 DISPOSABLE MARKED SPRING TIP GUIDEWIRE WAS BEING USED ON (B)(6) 2023 DURING AN EGD PROCEDURE AND THE ¿SAVORY WIRE WAS BENT DURING USE DURING AN EGD. THIS HAS BEEN OCCURRING MULTIPLE TIMES DURING PROCEDURES. NO PHYSICAL INJURY OCCURRED TO PATIENT. DEFECTIVE WIRE SENT TO DEPARTMENTS EMI PERSON.". THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. FURTHER ASSESSMENT WAS SENT; HOWEVER, THE REPORTER RESPONDED THEY DID NOT HAVE ANY MORE INFORMATION REGARDING THIS INCIDENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397358 ↗
• MalfunctionMay 26, 2023Fracture; Fracture

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT ((B)(4)) ON 9MAY23. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST DEVICE, DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE. IT WAS STATED THAT THE DEVICE WAS BEING USED DURING AN ENDOSCOPY PROCEDURE THAT OCCURRED ON (B)(6) 2023. THE REPORT STATED, ¿WE HAVE HAD MULTIPLE INCIDENTS WHERE CONMED DISPOSABLE GUIDE WIRES HAVE SNAPPED PARTIALLY THROUGH. THIS ISSUE HAS INVOLVED AT LEAST 2 DIFFERENT LOT NUMBERS THAT WE ARE AWARE OF.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THERE WAS NO REPORT OF FRAGMENTATION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009084 ↗
• MalfunctionMay 26, 2023Fracture; Fracture

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (B)(4) ON 9MAY2023. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST DEVICE, DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE. IT WAS STATED THAT THE DEVICE WAS BEING USED DURING AN ENDOSCOPY PROCEDURE THAT OCCURRED ON (B)(6) 2023. THE REPORT STATED, "WE HAVE HAD MULTIPLE INCIDENTS WHERE CONMED DISPOSABLE GUIDE WIRES HAVE SNAPPED PARTIALLY THROUGH. THIS ISSUE HAS INVOLVED AT LEAST 2 DIFFERENT LOT NUMBERS THAT WE ARE AWARE OF." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THERE WAS NO REPORT OF FRAGMENTATION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009080 ↗
• MalfunctionMay 19, 2023Material Twisted/Bent; Material Twisted/Bent

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DIS150 DISPOSABLE MARKED SPRING TIP GUIDEWIRE WAS BEING USED ON AN UNKNOWN DATE DURING AN EGD PROCEDURE AND THE GUIDEWIRE BENT. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16964481 ↗
• MalfunctionMay 18, 2023Material Twisted/Bent; Material Twisted/Bent

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DIS150 DISPOSABLE MARKED SPRING TIP GUIDEWIRE WAS BEING USED ON 20MAR23 DURING AN EGD PROCEDURE AND THE GUIDEWIRE BENT. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955782 ↗
• InjuryMar 16, 2023Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DIS150 DISPOSABLE MARKED SPRING TIP GUIDEWIRE WAS BEING USED ON (B)(6) 2023 DURING A RIGID ESOPHAGEAL DILATION AND THE ¿SPRING TIP SNAPPED DURING PROCEDURE AND CUT PATIENTS' ESOPHAGUS¿. THERE WAS A SMALL CUT TO PATIENT¿S ESOPHAGUS / DISCOMFORT AFTER THE PROCEDURE. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE PROCEDURE WAS NOT COMPLETED, "THE PATIENT'S ESOPHAGUS PERFORATED FROM THE WIRE BREAKING AT THE SPRING TIP." THE DIS150 WAS UTILIZED AS A GUIDE FOR A RIGID DILATOR - USED NORMALLY AT THE TIME OF THE EVENT. THIS WAS THE FIRST USE OF THE DIS150. THE PERFORATION REQUIRED X-TACK SUTURING. THERE WAS A DELAY TO THE PROCEDURE, THE SALES REPRESENTATIVE STATED, ¿I AM UNSURE OF THE LENGTH, BUT MANAGEMENT OF THE PERFORATION ADDED TIME TO THE PROCEDURE.¿ THE PATIENT INITIALLY FELT SLIGHT DISCOMFORT POST-PROCEDURE. THE SALES REPRESENTATIVE STATED, ¿I HAVE NOT HEARD ANYTHING FROM THE HOSPITAL SO I WOULD ASSUME THE PATIENT IS FINE. THE PATIENT STAYED LONGER THAN NORMAL POST-PROCEDURE - I AM UNSURE THE EXACT LENGTH OF TIME. THE PATIENT WAS ABLE TO RETURN HOME THAT DAY.". THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 16554445 ↗
• MalfunctionFeb 15, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE, WAS USED DURING A TRIAL EGD ON THE DATE OF (B)(6) 2023 WHEN IT WAS REPORTED, ¿DIS150 GUIDEWIRE SPRING TIP BROKE INSIDE PATIENT DURING TRIAL. WAS ABLE TO RETRIEVE WITH RETRIEVAL NET.¿. AFTER FURTHER ASSESSMENT IT WAS REPORTED, ¿THE DEVICE DID BREAK INTO THE SURGICAL SITE. THE DEVICE/FRAGMENTATION WAS RETRIEVED WITH A RETRIEVAL NET.¿ THERE WAS NO REPORT OF A DELAY, PATIENT OR USER IMPACT, PROLONGED HOSPITALIZATION OR MEDICAL INTERVENTION FOR THE PATIENT. 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 16381244 ↗
• MalfunctionDec 19, 2022Material Twisted/Bent; Material Twisted/Bent

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE, WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON (B)(6) 2022, WHEN IT WAS REPORTED, ¿WHILE COMPLETING AN OVER - THE - WIRE SAVARY DILATION DURING AN ESOPHAGOGASTRODUODENOSCOPY, WITH SEQUENTIAL DILATIONS - 14MM, 16MM, AND 18MM, THE GUIDEWIRE BENT ALONG THE DISTAL SPRING TIP. THE BENDING WAS NOTED FOLLOWING THE 18MM DILATION¿. THE GUIDEWIRE WAS REMOVED WITHOUT ANY HARM OR DELAY AND THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. IT WAS REPORTED THE GUIDEWIRE DID NOT FRAGMENT AND THERE ARE NO REPORTS OF INJURY, MEDICAL INTERVENTION, OR ADDITIONAL HOSPITALIZATION. 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 16004326 ↗
• MalfunctionDec 19, 2022Material Twisted/Bent; Material Twisted/Bent

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE, WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON (B)(6) 2022. WHEN IT WAS REPORTED, ¿GI TEAM WAS PERFORMING AN ESOPHAGOGASTRODUODENOSCOPY WITH OVER - THE - WIRE ESOPHAGEAL DILATION. FOLLOWING DILATION, IT WAS NOTED THAT THE GUIDEWIRE WAS SEVERELY BENT ALONG THE DISTAL SPRING TIP.¿ THE GUIDEWIRE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATIVE DEVICE. THE GUIDEWIRE DID NOT BREAK AND THERE ARE NO REPORTS OF INJURY, SURGICAL INTERVENTION, OR AN EXTENDED STAY AT THE HOSPITAL FOR THE PATIENT. 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 16004256 ↗
• MalfunctionDec 7, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE, WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿DURING AN ESOPHAGEAL OTW DILATION, DIS150 GUIDEWIRE BROKE OFF NEAR THE START OF THE SPRING TIP. IT WAS SUCCESSFULLY REMOVED WITH RAT TOOTH FORCEPS.¿ AFTER A FURTHER ASSESSMENT, IT WAS REPORTED,¿ A PORTION OF THE GUIDEWIRE BROKE OFF AND WAS IN THE ESOPHAGUS¿. AFTER REMOVING THE DEVICE WITH RAT TOOTH FORCEPS, THE PROCEDURE WAS COMPLETED AND HAD NO PATIENT OR USER IMPACT. THE PATIENT DID NOT REQUIRE SURGICAL INTERVENTION OR AN EXTENDED STAY AT THE HOSPITAL. 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 15932608 ↗
• MalfunctionSep 13, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE, WAS BEING USED DURING AN EDG DILATION ON (B)(6) 2022 WHEN IT WAS REPORTED, PHYSICIAN DESCRIBED USING CLEANGUIDE GUIDEWIRE DURING A DILATION CASE, AND THE GUIDEWIRE KINKED WHILE IN THE RIGID DILATOR IN THE PATIENT'S ESOPHAGUS. INTRA-OP. THE PROCEDURE WAS COMPLETED WITH A 5-MINUTE DELAY USING AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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 15409531 ↗
• MalfunctionSep 13, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE, WAS BEING USED DURING AN EDG DILATION ON (B)(6) 2022 WHEN IT WAS REPORTED,¿PHYSICIAN DESCRIBED USING CLEANGUIDE GUIDEWIRE DURING A DILATION CASE, AND THE GUIDEWIRE KINKED WHILE IN THE RIGID DILATOR IN THE PATIENT'S ESOPHAGUS. INTRA-OP.¿. THE PROCEDURE WAS COMPLETED WITH A 5-MINUTE DELAY USING AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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 15409528 ↗
• MalfunctionSep 13, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DIS150, DISPOSABLE MARKED SPRING TIP GUIDEWIRE, WAS BEING USED DURING AN EDG DILATION ON (B)(6) 2022 WHEN IT WAS REPORTED,¿PHYSICIAN DESCRIBED USING CLEANGUIDE GUIDEWIRE DURING A DILATION CASE, AND THE GUIDEWIRE KINKED WHILE IN THE RIGID DILATOR IN THE PATIENT'S ESOPHAGUS. INTRA-OP.¿ THE PROCEDURE WAS COMPLETED WITH A 5-MINUTE DELAY USING AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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 15409527 ↗