OLYMPUS GWH3805RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925031449), received between May 3, 2021 and Dec 17, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2021Material Frayed; Material Frayed

  THE CUSTOMER REPORTED DURING A THERAPEUTIC FOLEY CATHETER PLACEMENT, THE SUBJECT DEVICE FRAYED ON REMOVAL WITHIN THE CATHETER TUBING. THE PATIENT WAS BEING CATHETERIZED POST-OPERATIVELY IN THE PACU BECAUSE THEY WERE NOT SPONTANEOUSLY VOIDING. UROLOGY WAS CONTACTED TO INSERT THE CATHETER TO AVOID URETHRAL TRAUMA. WHILE ADVANCING AN 18 FRENCH COUDE FOLEY CATHETER INTO THE URETHRA, RESISTANCE WAS MET AT THE EXPECTED POSITION OF THE BULBAR URETHRA AND THE CATHETER WAS REMOVED. NEXT THE SUBJECT DEVICE WAS ADVANCED INTO THE BLADDER AND A 5 FRENCH POLLACK CATHETER WAS USED TO CONFIRM POSITIONING IN THE BLADDER. THEN A 6 FRENCH COUNCIL TIP CATHETER WAS ATTEMPTED TO BE ADVANCED OVER THE WIRE HOWEVER SIMILAR RESISTANCE WAS ENCOUNTERED AT THE LEVEL OF THE BULBAR URETHRA AND THE CATHETER WAS REMOVED. NEXT A 14 FRENCH SILICONE CATHETER WAS USED AS A COUNCIL TIP CATHETER BY PUNCTURING THE TIP WITH THE ANGIOCATHETER; THIS WAS THEN ADVANCED OVER THE WIRE INTO THE BLADDER WITH A RETURN OF MORE THAN ONE (1) LITER OF CLEAR YELLOW URINE. UPON REMOVAL OF THE SUBJECT DEVICE, THE WIRE FRAYED WITHIN THE CATHETER TUBING. SINCE THE WIRE COULD NOT BE REMOVED IN IT'S ENTIRETY, THE CATHETER AND THE WIRE WERE R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13031143 ↗
• MalfunctionMay 3, 2021Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC URETEROSCOPY PROCEDURE, THE DISTAL TIP OF THE 0.038" HYBRID WIRE HAD BROKEN. A SMALL SECTION OF THE HYDROPHILIC TIP CRUMBLED OFF AND FELL INSIDE THE PATIENT. THE PART THAT FELL INSIDE THE PATIENT WAS SMALL SO THAT IT WAS NOT RETRIEVED. THE FRAGMENT WAS DISCOVERED AS THE BLADDER OF THE PATIENT WAS WASHED OUT AT THE END OF THE CASE. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY OR COMPLICATION TO THE PATIENT. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766228 ↗
• MalfunctionMay 3, 2021Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC URETEROSCOPY PROCEDURE, THE DISTAL TIP OF THE 0.038" HYBRID WIRE HAD BROKEN. A SMALL SECTION OF THE HYDROPHILIC TIP CRUMBLED OFF AND FELL INSIDE THE PATIENT. THE PART THAT FELL INSIDE THE PATIENT WAS SMALL, SO IT WAS NOT RETRIEVED. THE FRAGMENT WAS DISCOVERED AS THE BLADDER OF THE PATIENT WAS WASHED OUT AT THE END OF THE CASE. THE USER DID NOT RECALL CLEARLY, HOWEVER, STATED THAT SOME SMALL PIECES WERE RETRIEVED FROM THE PATIENT BUT NOT ALL. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY OR COMPLICATION TO THE PATIENT. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766129 ↗
• MalfunctionMay 3, 2021Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC URETEROSCOPY PROCEDURE TO REMOVE A URETERAL STONE, THE DISTAL TIP OF THE 0.038" HYBRID WIRE HAD BROKEN. THE LASER WAS USED TO BREAK THE STONE, BUT IT WAS IN THE LOWER THIRD OF THE URETER. FRAGMENTS OF THE URETERAL CALCULUS WERE RETRIEVED, AND A STENT WAS INSERTED. AT THE END OF THE CASE, THE WIRE WAS PULLED FROM THE STENT AND WAS BOUND UP BUT RELEASED AND WAS PULLED OUT. WHEN THE USER USED THE C-ARM TO VIEW THE STENT, THERE WAS FOREIGN MATERIAL IN THE KIDNEY OF THE PATIENT. THE WIRE WAS CHECKED, AND THE DISTAL TIP OF THE WIRE (HALF OF THE HYDROPHILIC TIP) HAD BROKEN OFF AND REMAINED IN THE PATIENT. THE USER HAD TO PULL THE STENT AGAIN AND GO BACK INTO THE KIDNEY TO EXTRACT THE PIECE THAT WAS MISSING FROM THE WIRE. TO COMPLETE THE PROCEDURE, ANOTHER GUIDEWIRE AND BASKET WERE USED. THERE WAS A SURGICAL DELAY OF APPROXIMATELY FIFTEEN (15) MINUTES. THERE WAS NO HARM TO THE PATIENT OTHER THAN THE INCREASED SURGERY TIME. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11761495 ↗