OLYMPUS GWH3505RRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00821925031425), received between Jan 14, 2021 and Sep 20, 2023 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  OLYMPUS RECEIVED INFORMATION FROM A CUSTOMER AS WELL AS FROM A MEDWATCH MW5145154 THAT THE TIP OF THE 0.035" HYBRID WIRE BROKE OFF IN THE PATIENT. ANOTHER WIRE WAS USED, WHICH ALSO BROKE OFF. THE FIRST WIRE FAILED IN THE BLADDER AND WAS EASILY RETRIEVED. THE SECOND WIRE BROKE OFF IN THE LEFT KIDNEY AND REQUIRED ADDITIONAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THAT THE EVENT OCCURRED DURING A URETEROSCOPY/LASER LITHOTRIPSY/STENT INSERTION PROCEDURE. THE CUSTOMER FURTHER CLARIFIED THAT THE PIECES WERE RETRIEVED WITH A GRASPER WITHOUT ANY ADDITIONAL TREATMENT NEEDED. THE PROCEDURE WAS PROLONGED, AND THE PATIENT'S ANESTHESIA WAS EXTENDED BY OVER 60 MINUTES. HOWEVER, THE REPORTED PROBLEM DID NOT AFFECT THE OUTCOME OF THE PROCEDURE, NOR DID IT IMPACT THE CONDITION OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITHOUT FURTHER HARM OR USER INJURY REPORTED. THE PATIENT ALSO DID NOT REQUIRE ANY FURTHER MEDICAL INTERVENTION AND IS CURRENTLY STABLE. THE DEVICE WAS INSPECTED PRIOR TO USE AS PER THE INSTRUCTIONS FOR USE (IFU). THE MEDWATCH FOR PATIENT IDENTIFIER (B)(6) CAPTURES THE FIRST GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17780652 ↗
• InjurySep 20, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  OLYMPUS RECEIVED INFORMATION FROM A CUSTOMER AS WELL AS FROM A MEDWATCH MW5145154 THAT THE TIP OF THE 0.035" HYBRID WIRE BROKE OFF IN THE PATIENT. ANOTHER WIRE WAS USED, WHICH ALSO BROKE OFF. THE FIRST WIRE FAILED IN THE BLADDER AND WAS EASILY RETRIEVED. THE SECOND WIRE BROKE OFF IN THE LEFT KIDNEY AND REQUIRED ADDITIONAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THAT THE EVENT OCCURRED DURING A URETEROSCOPY/LASER LITHOTRIPSY/STENT INSERTION PROCEDURE. THE CUSTOMER FURTHER CLARIFIED THAT THE PIECES WERE RETRIEVED WITH A GRASPER WITHOUT ANY ADDITIONAL TREATMENT NEEDED. THE PROCEDURE WAS PROLONGED, AND THE PATIENT'S ANESTHESIA WAS EXTENDED BY OVER 60 MINUTES. HOWEVER, THE REPORTED PROBLEM DID NOT AFFECT THE OUTCOME OF THE PROCEDURE, NOR DID IT IMPACT THE CONDITION OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITHOUT FURTHER HARM OR USER INJURY REPORTED. THE PATIENT ALSO DID NOT REQUIRE ANY MEDICAL INTERVENTION AND IS CURRENTLY STABLE. THE DEVICE WAS INSPECTED PRIOR TO USE AS PER THE INSTRUCTIONS FOR USE (IFU). THE MEDWATCH FOR PATIENT IDENTIFIER (B)(6) CAPTURES THE SECOND GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17780624 ↗
• MalfunctionDec 21, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THE HYBRID WIRE WAS DEFECTIVE. ACCORDING TO THE INITIAL REPORTER, THE OUTER JACKET PEELED OFF WHEN IT WAS REMOVED. REPORTEDLY, THIS TOOK PLACE DURING A DIAGNOSTIC PROCEDURE, AND THE PROCEDURE WAS CONFIRMED COMPLETED WITH THE SUBJECT DEVICE WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16024601 ↗
• InjuryDec 2, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTS DURING A RETROGRADE INTRA-RENAL SURGERY (RIRS) USING A 0.035" HYBRID WIRE AND A LASER, THE TIP OF THE GUIDEWIRE FELL OFF AS IT WAS TAKEN OUT OF THE KIDNEY (THE GUIDEWIRE TIP WAS PEELED OFF). THE DEVICE FRAGMENT WAS REMOVED IMMEDIATELY BY THE PHYSICIAN. THERE WAS NO HARM/INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED NORMALLY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER THE PROCEDURE. CONCOMITANT DEVICES USED DURING THE PROCEDURE INCLUDED OTHER COMPANIES¿ PRODUCTS. THIS INFORMATION COULD NOT BE PROVIDED. NO CONCOMITANT DEVICE MALFUNCTIONED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906563 ↗
• InjuryDec 1, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING A 0.035" HYBRID WIRE, A PIECE OF THE GUIDEWIRE BROKE OFF IN THE PATIENT'S URETER. THE PIECE WAS RETRIEVED. THE PLANNED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15893214 ↗
• MalfunctionNov 11, 2022Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, WHEN THE DEVICE WAS OPENED DURING PREPARATION FOR USE FOR A THERAPEUTIC RETROGRADE INTRA-RENAL SURGERY, IT WAS OBSERVED THAT THE GUIDEWIRE WAS BENT, AND THE DEVICE UNUSABLE. THE INTENDED PROCEDURE WAS PERFORMED AND COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15781345 ↗
• MalfunctionAug 30, 2022Accessory Incompatible; Accessory Incompatible

  THE CUSTOMER REPORTED TO OLYMPUS THAT A COOK MEDICAL URETERAL STINT MALFUNCTIONED WHEN USING THE OLYMPUS GUIDE WIRE . THE REPORTED PROBLEM WAS FOUND DURING A THERAPEUTIC URETEROSCOPY, WHICH WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320367 ↗
• MalfunctionAug 24, 2022Material Frayed; Material Frayed

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EXTERNAL PART OF THE GUIDEWIRE WAS FRAYED. THE REPORTED PROBLEM WAS FOUND DURING PREPARATION FOR A RETROGRADE INTRARENAL SURGERY, WHICH WAS COMPLETED WITH A NEW WIRE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15284795 ↗
• MalfunctionJul 21, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED , WHEN THE PACKAGE WAS OPENED THE INNER COIL WIRE FOUND PROTRUDING PAST THE HYDROPHILIC TIP, OR THE WIRE BROKE. THERE IS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075884 ↗
• MalfunctionMay 17, 2021Material Separation; Material Separation

  IT IS REPORTED DURING AN UNSPECIFIED PROCEDURE USING A 0.035" HYBRID WIRE, THE DEVICE WAS TORN WHEN PULLED OUT OF THE PATIENT (BROKE OUTSIDE OF THE PATIENT). THERE WAS NO PATIENT IMPACT RELATED TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832548 ↗
• MalfunctionMay 17, 2021Material Separation; Material Separation

  IT IS REPORTED DURING AN UNSPECIFIED PROCEDURE USING A 0.035" HYBRID WIRE, THE DEVICE WAS TORN WHEN PULLED OUT OF THE PATIENT (BROKE OUTSIDE OF THE PATIENT). THERE WAS NO PATIENT IMPACT RELATED TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832511 ↗
• MalfunctionMay 14, 2021Material Separation; Material Separation

  IT IS REPORTED DURING AN UNSPECIFIED PROCEDURE USING A 0.035" HYBRID WIRE, THE DEVICE WAS TORN WHEN PULLED OUT OF THE PATIENT (BROKE OUTSIDE OF THE PATIENT). THERE WAS NO PATIENT IMPACT RELATED TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829591 ↗
• InjuryApr 27, 2021Material Separation; Material Separation

  IT IS REPORTED DURING AN URETEROSCOPY PROCEDURE USING A HYBRID GUIDEWIRE AND A 22FR RIGID CYSTOSCOPE IN A PATIENT WITH A KIDNEY IMPACTED WITH STONE, THE GUIDEWIRE BROKE INSIDE THE PATIENT WHILE A STENT WAS BEING PLACED. THE PHYSICIAN REPORTS THERE WAS RÉSISTANCE ENCOUNTERED DURING THE CASE BUT IT WAS "NOTHING OUT OF THE ORDINARY". NO LASER OR STONE RETRIEVAL DEVICE WAS USED IN THE CASE. NINE DAYS LATER A SECOND PROCEDURE WAS PERFORMED TO REMOVE THE GUIDEWIRE FRAGMENT AND REMAINING STONE BURDEN. WHEN THE PHYSICIAN GRABBED THE GUIDEWIRE AND IT BROKE INTO EVEN SMALLER PIECES. THERE HAS BEEN NO RENAL IMPAIRMENT OR OTHER ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE RETAINED DEVICE FRAGMENTS. THE PATIENT'S CURRENT CONDITION IS DESCRIBED AS STABLE WITH RESIDUAL DEVICE FRAGMENTS REMAINING.

  Patient problems: Foreign Body In Patient

  MAUDE report 11733882 ↗
• MalfunctionJan 14, 2021Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 25JAN2021. AFTER THE PROCEDURE, THE USER CHECKED THE CONDITION OF THE PATIENT WITH C-ARM AND THERE WERE NO PIECE OF BROKEN TIPS WHICH NEED TO BE RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11174584 ↗
• MalfunctionJan 14, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE HYDROPHILIC COATING OF THE .035" HYBRID WIRE WAS DETACHED INSIDE THE PATIENT'S BODY DURING A RETROGRADE INTRARENAL SURGERY. THE COATING WAS REPORTED TO BE DETACHED AT THE MIDDLE AND IN MULTIPLE PIECES. THE USER WAS ABLE TO RETRIEVE ALL OF THE PIECES. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. NO PATIENT HARM OR IMPACT WAS REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11174550 ↗
• MalfunctionJan 14, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE END OF THE HYDROPHILIC TIP OF THE .035" HYBRID WIRE WAS DETACHED INSIDE THE PATIENT'S BODY DURING A RETROGRADE INTRARENAL SURGERY. THE DETACHED TIP WAS BROKEN INTO MULTIPLE PIECES AND ALL PIECES WERE RETRIEVED BY THE USER. THE PROCEDURE WAS COMPLETED WITH A SIMILAR REPLACEMENT DEVICE. THERE WAS NO HARM OR IMPACT TO THE PATIENT REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11174080 ↗