FUJIFILM EC-760R-V/LRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04547410358681), received between Sep 13, 2019 and Jul 23, 2025 — classified as 12 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (5 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2025Material Deformation; Material Deformation

  ON JUNE 25TH 2025, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L VIA MEDSUN REPORT, (B)(4) FROM FDA. IT WAS REPORTED THAT, ON (B)(6) 2025, DURING A COLONOSCOPY SCREENING FOR COLORECTAL CANCER, THE PHYSICIAN REALIZED THAT THE BIG WHEEL PART OF THE SCOPE HAD BROKEN MIDWAY THROUGH THE PROCEDURE. THE PHYSICIAN WAS STILL ABLE TO VISUALIZE AND WITHDREW THE SCOPE. THE SCOPEWAS THEN USED TO RETROFLEX IN THE RECTUM, AND AFTER THE RECTUM WAS VISUALIZED, A PERFORATION WAS NOTED. THE SCOPE WAS THEN CHANGED OUT TO AN EGD SCOPE. THE ANGULATION CONTROL KNOB IS BROKEN ON THE DEVICE.

  Patient problems: Bowel Perforation

  MAUDE report 22583983 ↗
• MalfunctionJul 3, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE JET WASH CHANNEL IS TOO STRONG AND IT DAMAGED TISSUE. THE PATIENT REMAINED STABLE, WAS DISCHARGED, AND FOLLOW-UP CONFIRMED FULL RECOVERY. ISSUE RESOLVED WHEN THE FLOW OF THE ENDO GATOR DESCREASED BY THE CUSTOMER.

  Patient problems: Abrasion

  MAUDE report 22393716 ↗
• MalfunctionApr 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BLACK STUFF WAS COMING OUT OF THE SCOPE AFTER THE PROCEDURE. AT THE END OF THE CASE, THE TECH OF THE FACILITY SAID THE SCOPE MADE A "WEIRD" NOISE WHEN FLUSHING THE SCOPE. IT WAS THEN TAKEN TO THE SCOPE CLEANING ROOM AND DURING THE BRUSHING OF THE SUCTION CHAMBER, SMALL BLACK PARTICLES CAME OUT OF THE SCOPE. THEY FELT LIKE HARD PLASTIC PIECES OF WHAT THE SCOPE IS MADE OUT OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21888060 ↗
• MalfunctionJun 20, 2024Increase in Pressure; Increase in Pressure

  ON MAY 20TH FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. IT WAS REPORTED THAT THE DEVICE IS PUSHING TOO MUCH FLUID AND HURTING THE PATIENT. THE PATIENT WAS HURTING HIS COLON/STOMACH. PATIENT IS STABLE AND HAD NO FURTHER COMPLICATIONS POST PROCEDURE. NO MEDICAL INTERVENTION WAS NEEDED. THE SITE WAS NOT ABLE TO RETRIEVE THE POLYP. THE MUCOSAL LINING WAS DAMAGED, SO NO CLEAR BIOPSY COULD BE TAKEN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraoperative Pain

  MAUDE report 19576065 ↗
• MalfunctionApr 26, 2024Gas/Air Leak; Gas/Air Leak

  ON MARCH 29TH 2024 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. IT WAS REPORTED THAT LEAKS WERE IDENTIFIED AT THE CO2 INSUFFLATION CONNECTION POINT AND WOULD NOT ALLOW FOR BOWEL INSUFFLATION. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19194107 ↗
• MalfunctionApr 26, 2024Break; Material Fragmentation; Break; Material Fragmentation

  ON MARCH 28TH 2024 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. IT WAS REPORTED THAT THE ANGULATION KNOB SNAPPED DURING A DIAGNOSTIC. THERE WAS NO HARM OR INJURY TO THE PATIENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192929 ↗
• MalfunctionJan 30, 2024Suction Problem; Suction Failure; Suction Problem; Suction Failure

  ON JANUARY 3RD 2024 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE THE SUCTIONS WAS NOT WORKING PROPERLY. THE PROCEDURE WAS PROLONGED DUE THE PHYSICIAN WAS UNABLE TO SUCTION PROPERLY. THERE WAS NO HARM OR INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610260 ↗
• MalfunctionJan 26, 2024Partial Blockage; Partial Blockage

  ON (B)(6) 2023 FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. IT WAS REPORTED THAT THE SCOPE IS SPRAYING A DOUBLE WATER STREAM OUT OF THE DISTAL TIP, THERE IS DIFFICULTY PUTTING THE FIRST STEP THROUGH THE WATER CHANNEL AND THE BLUE WATER INDICATOR RING AROUND THE WATER BUTTON NEEDS TO BE REPLACED. THE PATIENT RECEIVED MINOR MICRO TEARING OF THE MUCOSA. NO INTERVENTION OR TREATMENT WAS NEEDED. THERE WAS NO PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18585952 ↗
• MalfunctionJan 26, 2024Partial Blockage; Partial Blockage

  ON (B)(6), 2023, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. IT WAS REPORTED THAT THERE IS A CLOG IN THE DISTAL CO2 CHANNEL. CO2 IS NOT COMING OUT AND WAS UNABLE TO BE USED DURING PATIENT CARE. ROOM AIR WAS USED INSTEAD. THE CASE TOOK LONGER WHILE ATTEMPTING TO TROUBLESHOOT, AND CARE DEVIATED FROM THE NORMAL PROTOCOL. THE PATIENT REMAINED SAFE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18585951 ↗
• MalfunctionJan 4, 2024Blocked Connection; Device Handling Problem; Blocked Connection; Device Handling Problem

  ON DECEMBER 5TH, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. IT WAS REPORTED THAT THERE IS A CLOG IN THE DISTAL CO2 CHANNEL. CO2 IS NOT COMING OUT AND WAS UNABLE TO BE USED DURING PATIENT CARE. ROOM AIR WAS USED INSTEAD. THE CASE TOOK LONGER WHILE ATTEMPTING TO TROUBLESHOOT, AND CARE DEVIATED FROM THE NORMAL PROTOCOL. THE PATIENT REMAINED SAFE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM OR INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443760 ↗
• InjuryDec 29, 2023Free or Unrestricted Flow; Free or Unrestricted Flow

  ON (B)(6) 2023 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. IT WAS REPORTED THAT THE SCOPE IS SPRAYING A DOUBLE WATER STREAM OUT OF THE DISTAL TIP, THERE IS DIFFICULTY PUTTING THE FIRST STEP THROUGH THE WATER CHANNEL AND THE BLUE WATER INDICATOR RING AROUND THE WATER BUTTON NEEDS TO BE REPLACED. THE PATIENT RECEIVED MINOR MICRO TEARING OF THE MUCOSA. NO INTERVENTION OR TREATMENT WAS NEEDED. THERE WAS NO PROCEDURE DELAY.

  Patient problems: Laceration(s)

  MAUDE report 18419341 ↗
• MalfunctionNov 6, 2023No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. IT WAS REPORTED THAT THE CABLE SNAPPED DURING THE PROCEDURE. THE DELAY WAS THAT THE CUSTOMER HAD TO CHANGED THE SCOPE OUT DURING THE PROCEDURE. THERE WAS NO MAJOR DELAY, AND THE PATIENT WAS NOT IMPACTED. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074458 ↗
• MalfunctionOct 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON SEPTEMBER 8TH, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. IT WAS REPORTED THAT THE LIGHT SOURCE IS VERY DIM. THE CUSTOMER HAS TROUBLE TO SEE IF IT WAS A SCOPE LIGHT FAILURE OR LIGHT SOURCE FAILURE. IT WAS DETERMINED TO BE THE SCOPE LIGHT FAILURE. THERE IS NO SERIOUS INJURY OR DEATH ASSOCIATED WITH THE EVENT. THEREFORE, THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886716 ↗
• MalfunctionSep 7, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON AUGUST 8, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. IT WAS REPORTED THAT CUSTOMER REQUESTED ADVICE ON A POTENTIAL INFECTION CONTROL ISSUE. THEY HAD AN INEXPERIENCED SCOPE TECH PUT ¼ - 1/2 CUP OF EMPOWER ENZYMATIC SOLUTION INTO ONE OF THEIR MEDIVATORS DSD WASHERS WHERE THE OPA WAS SUPPOSED TO GO, AND TWO OF THE SCOPES THAT WERE RUN THROUGH THERE WERE USED ON PATIENTS BEFORE THEY CAUGHT THE MISTAKE. THERE IS NO SERIOUS INJURY OR DEATH ASSOCIATED WITH THE EVENT. THEREFORE, THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17701856 ↗
• InjuryAug 31, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON MAY 22, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. IT WAS REPORTED THAT CUSTOMER REQUESTED ADVICE ON A POTENTIAL INFECTION CONTROL ISSUE. THEY HAD AN INEXPERIENCED SCOPE TECH PUT ¼ - 1/2 CUP OF EMPOWER ENZYMATIC SOLUTION INTO ONE OF THEIR MEDIVATORS DSD WASHERS WHERE THE OPA WAS SUPPOSED TO GO, AND TWO OF THE SCOPES THAT WERE RUN THROUGH THERE WERE USED ON PATIENTS BEFORE THEY CAUGHT THE MISTAKE. THERE IS NO SERIOUS INJURY OR DEATH ASSOCIATED WITH THE EVENT. THEREFORE, THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666059 ↗
• InjuryAug 31, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON MAY 22, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. IT WAS REPORTED THAT CUSTOMER REQUESTED ADVICE ON A POTENTIAL INFECTION CONTROL ISSUE. THEY HAD AN INEXPERIENCED SCOPE TECH PUT ¼ - 1/2 CUP OF EMPOWER ENZYMATIC SOLUTION INTO ONE OF THEIR MEDIVATORS DSD WASHERS WHERE THE OPA WAS SUPPOSED TO GO, AND TWO OF THE SCOPES THAT WERE RUN THROUGH THERE WERE USED ON PATIENTS BEFORE THEY CAUGHT THE MISTAKE. THERE IS NO SERIOUS INJURY OR DEATH ASSOCIATED WITH THE EVENT. THEREFORE, THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17665921 ↗
• InjuryJul 25, 2023Sharp Edges; Sharp Edges

  ON JULY 6, 2023, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. THIS REPORT ADDRESSES THE THIRD OF THREE EVENTS THAT OCCURRED AT THE USER FACILITY USING THE SAME SCOPE. IT WAS REPORTED THAT DURING A PROCEDURE THE PATIENT EXPERIENCED AN ABRASION OF THE CECUM THAT IS SUSPECTED TO HAVE BEEN CAUSED BY A SHARP POINT ON THE DISTAL END. THE SCOPE WAS SWITCHED CAUSING A SLIGHT DELAY. THEREAFTER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THERE IS NO DEATH ASSOCIATED WITH THE EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: Abrasion

  MAUDE report 17390525 ↗
• InjuryJul 25, 2023Sharp Edges; Sharp Edges

  ON JUNE 27, 2023, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. THIS REPORT ADDRESSES THE SECOND OF THREE EVENTS THAT OCCURRED AT THE USER FACILITY USING THE SAME SCOPE. IT WAS REPORTED THAT DURING A PROCEDURE THE PATIENT EXPERIENCED A MINOR COLON ABRASION THAT IS SUSPECTED TO HAVE BEEN CAUSED BY A SHARP POINT ON THE DISTAL END. THE SCOPE WAS SWITCHED CAUSING A SLIGHT DELAY. THEREAFTER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THERE IS NO DEATH ASSOCIATED WITH THE EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: Abrasion

  MAUDE report 17390505 ↗
• MalfunctionJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. THIS REPORT ADDRESSES THE FIRST OF THREE EVENTS THAT OCCURRED AT THE USER FACILITY USING THE SAME SCOPE. IT WAS REPORTED THAT DURING A PROCEDURE THE PATIENT EXPERIENCED A MINOR COLON ABRASION THAT IS SUSPECTED TO HAVE BEEN CAUSED BY A SHARP POINT ON THE DISTAL END. THE SCOPE WAS SWITCHED CAUSING A SLIGHT DELAY. THEREAFTER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THERE IS NO DEATH ASSOCIATED WITH THE EVENT.

  Patient problems: Abrasion

  MAUDE report 17328844 ↗
• InjuryJul 7, 2023Sharp Edges; Sharp Edges

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. THIS REPORT ADDRESSES THE FIRST OF THREE EVENTS THAT OCCURRED AT THE USER FACILITY USING THE SAME SCOPE. IT WAS REPORTED THAT DURING A PROCEDURE THE PATIENT EXPERIENCED A MINOR COLON ABRASION THAT IS SUSPECTED TO HAVE BEEN CAUSED BY A SHARP POINT ON THE DISTAL END. THE SCOPE WAS SWITCHED CAUSING A SLIGHT DELAY. THEREAFTER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THERE IS NO DEATH ASSOCIATED WITH THE EVENT. DURING A RETROSPECTIVE REVIEW, IT WAS DETERMINED THAT THIS EVENT SHOULD BE REPORTED IN ABUNDANCE OF CAUTION.

  Patient problems: Abrasion

  MAUDE report 17283348 ↗
• InjuryJul 7, 2023Sharp Edges; Sharp Edges

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. THIS REPORT ADDRESSES THE SECOND OF THREE EVENTS THAT OCCURRED AT THE USER FACILITY USING THE SAME SCOPE. IT WAS REPORTED THAT DURING A PROCEDURE THE PATIENT EXPERIENCED A MINOR COLON ABRASION THAT IS SUSPECTED TO HAVE BEEN CAUSED BY A SHARP POINT ON THE DISTAL END. THE SCOPE WAS SWITCHED CAUSING A SLIGHT DELAY. THEREAFTER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THERE IS NO DEATH ASSOCIATED WITH THE EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: Abrasion

  MAUDE report 17283346 ↗
• InjuryJul 7, 2023Sharp Edges; Sharp Edges

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760R-V/L. THIS REPORT ADDRESSES THE THIRD OF THREE EVENTS THAT OCCURRED AT THE USER FACILITY USING THE SAME SCOPE. IT WAS REPORTED THAT DURING A PROCEDURE THE PATIENT EXPERIENCED AN ABRASION OF THE CECUM THAT IS SUSPECTED TO HAVE BEEN CAUSED BY A SHARP POINT ON THE DISTAL END. THE SCOPE WAS SWITCHED CAUSING A SLIGHT DELAY. THEREAFTER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THERE IS NO DEATH ASSOCIATED WITH THE EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: Abrasion

  MAUDE report 17283345 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 06 NOV 2019 FUJIFILM MEDICAL SYSTEMS U.S.A., INC (FMSU) WAS INFORMED THAT A SMALL PERFORATION WAS DISCOVERED IN A PATIENT AFTER ROUTINE COLONOSCOPY ON A PATIENT WITH CROHN'S DISEASE. PATIENT 1: THE PHYSICIAN INDICATED THAT THE COLON WAS TORTUROUS AND FULL OF STOOL AND THERE WAS DIFFICULTY GETTING INTO THE ILEOCECAL VALVE; HE SUCCEEDED AND WITHDREW THE SCOPE. SHORTLY AFTER PROCEDURE THE PATIENT STARTED TO EXHIBIT SOME PAIN AND IT WAS DETERMINED WITH X-RAY THAT HE HAD A SMALL PERFORATION NEAR THE CECUM. DUE TO THE PATIENT HAVING CROHN'S DISEASE AND IT BEING A COMPLICATION, THE SCOPE WAS NOT CONSIDERED TO BE A CAUSE AT THAT TIME. THE PATIENT HAS HAD SURGERY TO CORRECT THE PERFORATION. PATIENT 2: THE FOLLOWING WEEK A COLONOSCOPY PROCEDURE WAS PERFORMED WITH SOME DIFFICULTY ON PATIENT 2, THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE. THE PHYSICIAN STATED THAT AT ONE POINT OF THE PROCEDURE WHERE HE WAS RUNNING THE TIP OF THE SCOPE CLOSE TO THE MUCOSA, HE NOTICED, WHAT WAS DESCRIBED AS A "RED LINE OR SCRATCH" ON THE MUCOSA. THE PHYSICIAN ASKED THE TECHNICIAN IF THE SCOPE WAS THE SAME SCOPE THAT WAS USED THE WEEK PRIOR WITH THE PERFORATION CASE (PATIENT 1); IT WAS DETERMINED THAT IT

  Patient problems: Perforation

  MAUDE report 9398650 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 06 NOV 2019 FUJIFILM CORPORATION WAS INFORMED THAT A SMALL PERFORATION WAS DISCOVERED IN A PATIENT AFTER ROUTINE COLONOSCOPY ON A PATIENT WITH CROHN'S DISEASE. PATIENT 1: THE PHYSICIAN INDICATED THAT THE COLON WAS TORTUROUS AND FULL OF STOOL AND THERE WAS DIFFICULTY GETTING INTO THE ILEOCECAL VALVE; HE SUCCEEDED AND WITHDREW THE SCOPE. SHORTLY AFTER PROCEDURE THE PATIENT STARTED TO EXHIBIT SOME PAIN AND IT WAS DETERMINED WITH X-RAY THAT HE HAD A SMALL PERFORATION NEAR THE CECUM. DUE TO THE PATIENT HAVING CROHN'S DISEASE AND IT BEING A COMPLICATION, THE SCOPE WAS NOT CONSIDERED TO BE A CAUSE AT THAT TIME. THE PATIENT HAD SURGERY TO CORRECT THE PERFORATION. PATIENT 2: THE FOLLOWING WEEK A COLONOSCOPY PROCEDURE WAS PERFORMED WITH SOME DIFFICULTY ON PATIENT 2, THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE. THE PHYSICIAN STATED THAT AT ONE POINT OF THE PROCEDURE WHERE HE WAS RUNNING THE TIP OF THE SCOPE CLOSE TO THE MUCOSA, HE NOTICED, WHAT WAS DESCRIBED AS A "RED LINE OR SCRATCH" ON THE MUCOSA. THE PHYSICIAN ASKED THE TECHNICIAN IF THE SCOPE WAS THE SAME SCOPE THAT WAS USED THE WEEK PRIOR WITH THE PERFORATION CASE (PATIENT 1); IT WAS DETERMINED THAT IT WAS. THE PROCEDURE ON PATIE

  Patient problems: Perforation

  MAUDE report 9398632 ↗
• InjurySep 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2019 FUJIFILM CORPORATION WAS INFORMED THAT A POLYPECTOMY PROCEDURE WITH A FUJIFILM ENDOSCOPE RESULTED IN A MUCOSAL ABRASION/TEAR. THE IN-ROOM TECHNICIAN INDICATED THAT THE PHYSICIAN WAS USING THE NUMBER 3 SETTING ON THE FAM ALONG WITH A THIRD PARTY STIFFENING WIRE (STIFFEST MODEL) WHILE THE TECHNICIAN WAS APPLYING PRESSURE. THE PHYSICIAN SAID THAT THE PATIENT WAS BEING TREATED FOR POLYPS AND THERE WAS SLIGHT TRAUMA TO THE COLON IN WHICH THE PHYSICIAN BELIEVED WAS ENDOSCOPIC SCOPE TRAUMA; A TEAR THAT WAS APPROXIMATELY 1.5 CM LONG. THE PHYSICIAN AND HIS MEDICAL STAFF BELIEVE IT WAS CAUSED BY THE RIDGES OF THE TIP OF THE SCOPE. IT WAS CONFIRMED THAT THERE WERE NO SERIOUS INJURIES AND THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE SAME SCOPE; THE TEAR WAS TREATED WITH CLIPS. AFTERWARDS, THE PATIENT WAS SENT FOR A CT SCAN AS A SAFETY PRECAUTION; THE RESULTS WERE NORMAL. THE PHYSICIAN CONFIRMED THAT THE PATIENT IS FINE, THE PATIENT WAS NOT HOSPITALIZED AND DID NOT NEED ADDITIONAL MEDICAL ATTENTION. THE PHYSICIAN WAS UNSURE HOW MANY OTHER PATIENTS RECEIVED TREATMENT WITH THE SAME SCOPE, HOWEVER, THERE WERE NO SIMILAR REPORTS OR PATIENT INJURY RELATED TO THIS SCOPE. THE PHYSICIA

  Patient problems: Abrasion

  MAUDE report 9041862 ↗