URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V (UDI 04953170287183)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170287183), received between Jul 19, 2018 and Mar 11, 2021 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE ARTICLE TITLED "BETWEEN A ROCK AND A HARD PLACE: A CASE REPORT OF STONE FRAGMENT IMPACTION CAUSING A RETAINED URETEROSCOPE REQUIRING OPEN SURGICAL INTERVENTION", A PATIENT EXPERIENCED PHYSICAL ENTRAPMENT OF THE COMPLAINT DEVICE REQUIRING SURGICAL INTERVENTION. AS REPORTED IN THE CASE STUDY, A (B)(6)-YEAR-OLD FEMALE UNDERWENT URETEROSCOPY FOR A 2 CM RIGHT URETEROPELVIC JUNCTION OBSTRUCTING STONE. AFTER LASER LITHOTRIPSY, THERE WAS SIGNIFICANT BUILDUP OF STONE DEBRIS DISTALLY ALONG THE URETEROSCOPE. CONSERVATIVE MEASURES FAILED TO REMOVE THE URETEROSCOPE. THE ENTRAPMENT OF THE DEVICE IS REPORTED TO BE DUE TO HEAVY STONE BURDEN SURROUNDING THE TIP OF THE DEVICE PREVENTING IT'S SAFE WITHDRAWAL. AN EXPLORATORY LAPAROTOMY THROUGH A TWO SIDES GIBSON INCISION AND RIGHT URETERAL DISSECTION FOR MANUAL REMOVAL OF THE STONE DEBRIS WAS PERFORMED WITH EVENTUAL REMOVAL OF THE RETAINED URETEROSCOPE. A URETERAL REIMPLANT WAS PERFORMED. POSTOPERATIVE COMPUTERIZED TOMOGRAPHY (CT) SHOWED RESIDUAL HYDRONEPHROSIS, BUT THERE WAS NO OBSTRUCTION SEEN ON RENAL LASIX SCAN. THERE IS NO REPORT OF DEVICE MALFUNCTION. THE STUDY CONCLUDED THAT URETEROSCOPIC TREATMENT OF LARGE

  Patient problems: Physical Entrapment

  MAUDE report 11465524 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  [OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿CLINICAL STUDY OF PCNL AND URS FOR KIDNEY STONES WITH A MAJOR AXIS OF 20 MM OR MORE¿. THE LITERATURE REPORTED THE RESULT OF 31 CASES OF URETERORENOSCOPY (URS) BETWEEN JANUARY 2013 AND DECEMBER 2017. THERE WAS A POSSIBILITY THAT URS WAS PERFORMED USING THE URF-V. IN THIS LITERATURE, IT WAS REPORTED ADVERSE EVENTS AS FOLLOWS; URETERAL INJURY: 2 CASES. FEVER: 4 CASES. FEVER (SEPTIC SHOCK): 1 CASE. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED ADVERSE EVENTS COULD NOT BE DETERMINED. OMSC IS SUBMITTING SEVEN MDRS ACCORDING TO THE NUMBER OF THE ADVERSE EVENTS. THIS IS 6 OF 7 REPORTS. (4 OF 4 FEVER CASES).

  Patient problems: Fever

  MAUDE report 9725592 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿CLINICAL STUDY OF PCNL AND URS FOR KIDNEY STONES WITH A MAJOR AXIS OF 20 MM OR MORE¿. THE LITERATURE REPORTED THE RESULT OF 31 CASES OF URETERORENOSCOPY (URS) BETWEEN JANUARY 2013 AND DECEMBER 2017. THERE WAS A POSSIBILITY THAT URS WAS PERFORMED USING THE URF-V. IN THIS LITERATURE, IT WAS REPORTED ADVERSE EVENTS AS FOLLOWS; URETERAL INJURY: 2 CASES. FEVER: 4 CASES. FEVER (SEPTIC SHOCK): 1 CASE. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED ADVERSE EVENTS COULD NOT BE DETERMINED. OMSC IS SUBMITTING SEVEN MDRS ACCORDING TO THE NUMBER OF THE ADVERSE EVENTS. THIS IS 7 OF 7 REPORTS. (FEVER (SEPTIC SHOCK): 1 CASE).

  Patient problems: Fever

  MAUDE report 9725590 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿CLINICAL STUDY OF PCNL AND URS FOR KIDNEY STONES WITH A MAJOR AXIS OF 20 MM OR MORE¿. THE LITERATURE REPORTED THE RESULT OF 31 CASES OF URETERORENOSCOPY (URS) BETWEEN JANUARY 2013 AND DECEMBER 2017. THERE WAS A POSSIBILITY THAT URS WAS PERFORMED USING THE URF-V. IN THIS LITERATURE, IT WAS REPORTED ADVERSE EVENTS AS FOLLOWS; URETERAL INJURY: 2 CASES. FEVER: 4 CASES. FEVER (SEPTIC SHOCK): 1 CASE. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED ADVERSE EVENTS COULD NOT BE DETERMINED. OMSC IS SUBMITTING SEVEN MDRS ACCORDING TO THE NUMBER OF THE ADVERSE EVENTS. THIS IS 5 OF 7 REPORTS. (3 OF 4 FEVER CASES).

  Patient problems: Fever

  MAUDE report 9725589 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿CLINICAL STUDY OF PCNL AND URS FOR KIDNEY STONES WITH A MAJOR AXIS OF 20 MM OR MORE¿. THE LITERATURE REPORTED THE RESULT OF 31 CASES OF URETERORENOSCOPY (URS) BETWEEN JANUARY 2013 AND DECEMBER 2017. THERE WAS A POSSIBILITY THAT URS WAS PERFORMED USING THE URF-V. IN THIS LITERATURE, IT WAS REPORTED ADVERSE EVENTS AS FOLLOWS; - URETERAL INJURY: 2 CASES. - FEVER: 4 CASES. - FEVER (SEPTIC SHOCK): 1 CASE. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED ADVERSE EVENTS COULD NOT BE DETERMINED. OMSC IS SUBMITTING SEVEN MDRS ACCORDING TO THE NUMBER OF THE ADVERSE EVENTS. THIS IS 3 OF 7 REPORTS. (1 OF 4 FEVER CASES).

  Patient problems: Fever

  MAUDE report 9725586 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿CLINICAL STUDY OF PCNL AND URS FOR KIDNEY STONES WITH A MAJOR AXIS OF 20 MM OR MORE¿. THE LITERATURE REPORTED THE RESULT OF 31 CASES OF URETERORENOSCOPY (URS) BETWEEN JANUARY 2013 AND DECEMBER 2017. THERE WAS A POSSIBILITY THAT URS WAS PERFORMED USING THE URF-V. IN THIS LITERATURE, IT WAS REPORTED ADVERSE EVENTS AS FOLLOWS; URETERAL INJURY: 2 CASES. FEVER: 4 CASES. FEVER (SEPTIC SHOCK): 1 CASE. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED ADVERSE EVENTS COULD NOT BE DETERMINED. OMSC IS SUBMITTING SEVEN MDRS ACCORDING TO THE NUMBER OF THE ADVERSE EVENTS. THIS IS 2 OF 7 REPORTS. (2 OF 2 URETERAL INJURY CASES).

  Patient problems: Injury

  MAUDE report 9725585 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿CLINICAL STUDY OF PCNL AND URS FOR KIDNEY STONES WITH A MAJOR AXIS OF 20 MM OR MORE¿. THE LITERATURE REPORTED THE RESULT OF 31 CASES OF URETERORENOSCOPY (URS) BETWEEN JANUARY 2013 AND DECEMBER 2017. THERE WAS A POSSIBILITY THAT URS WAS PERFORMED USING THE URF-V. IN THIS LITERATURE, IT WAS REPORTED ADVERSE EVENTS AS FOLLOWS; URETERAL INJURY: 2 CASES. FEVER: 4 CASES. FEVER (SEPTIC SHOCK): 1 CASE. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED ADVERSE EVENTS COULD NOT BE DETERMINED. OMSC IS SUBMITTING SEVEN MDRS ACCORDING TO THE NUMBER OF THE ADVERSE EVENTS. THIS IS 4 OF 7 REPORTS. (2 OF 4 FEVER CASES).

  Patient problems: Fever

  MAUDE report 9725584 ↗
• InjuryFeb 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿CLINICAL STUDY OF PCNL AND URS FOR KIDNEY STONES WITH A MAJOR AXIS OF 20 MM OR MORE¿. THE LITERATURE REPORTED THE RESULT OF 31 CASES OF URETERORENOSCOPY (URS) BETWEEN JANUARY 2013 AND DECEMBER 2017. THERE WAS A POSSIBILITY THAT URS WAS PERFORMED USING THE URF-V. IN THIS LITERATURE, IT WAS REPORTED ADVERSE EVENTS AS FOLLOWS; URETERAL INJURY: 2 CASES. FEVER: 4 CASES. FEVER (SEPTIC SHOCK): 1 CASE. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED ADVERSE EVENTS COULD NOT BE DETERMINED. OMSC IS SUBMITTING SEVEN MDRS ACCORDING TO THE NUMBER OF THE ADVERSE EVENTS. THIS IS 1 OF 7 REPORTS. (1 OF 2 URETERAL INJURY CASES).

  Patient problems: Injury

  MAUDE report 9716079 ↗
• InjuryJul 19, 2018Break; Break

  ON JULY 04TH, 2018, OLYMPUS RECEIVED LITERATURE TITLED ¿STEEP INFUNDIBULOPELVIC ANGLE (IPA) AS A NEW RISK FACTOR FOR FLEXIBLE URETEROSCOPE DAMAGE AND COMPLICATED POSTOPERATIVE COURSE¿ THAT WAS MADE IN PUBLIC IN EUROPEAN UROLOGY. IN THE LITERATURE, LONG-TERM HOSPITALIZATION, OR GRADE 2 OR MORE OF CLAVIEN-DINDO CLASSIFICATION WAS REPORTED AS COMPLICATIONS, BUT THE NUMBER OF COMPLICATIONS WAS NOT REPORTED. THE LITERATURE REPORTED THAT A NON-OLYMPUS URETERORENOSCOPE(FLEX-X2) AND AN OLYMPUS URETERORENOSCOPE(URF-V) AS THE ENDOSCOPIC EQUIPMENT USED FOR THE STUDY. HOWEVER, THE LITERATURE DID NOT DESCRIBE WHICH ENDOSCOPE MODEL WAS USED IN WHICH CASES. SINCE THE RELATIONSHIP BETWEEN THE NUMBER OF COMPLICATIONS AND THE SUBJECT DEVICE IS UNCLEAR, OLYMPUS SUBMIT ONE MEDICAL DEVICE REPORT. THE ABSTRACT OF THE LITERATURE IS AS FOLLOWS. [ABSTRACT]: INTRODUCTION &OBJECTIVES: THE INCREASING NUMBER OF FLEXIBLE URETERORENOSCOPY (FURS) PROCEDURES, THE FRAGILITY OF DEVICES AND THEIR GROWING REPAIR COSTS REPRESENT A SUBSTANTIAL BURDEN FOR UROLOGICAL DEPARTMENTS WORLDWIDE. NO RISK FACTORS OF FLEXIBLE URETEROSCOPE DAMAGE HAVE BEEN IDENTIFIED SO FAR. THE OBJECTIVE OF THIS STUDY WAS TO INVESTIGATE THE IMPACT

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7702002 ↗