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OLYMPUS OFP-2 (US)Recalls & reported problems

Keymed (Medical & Industrial Equipment) Limited · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
22
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 15019778003191), received between Mar 10, 2022 and May 21, 2024 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 4 reportsApr 2024: 7 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Aug 23, 2024Open, Classified

    During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.

    Z-0229-2025 · Root cause: Equipment maintenance · FDA record ↗

Most reported problems

Device problems

  • Energy Output Problem4
  • Pressure Problem4
  • Break3
  • Activation Problem2
  • Key or Button Unresponsive/not Working2
  • Connection Problem1
  • Difficult to Flush1
  • Difficult to Open or Close1

Patient problems

  • No Clinical Signs, Symptoms or Conditions14
  • Hemorrhage/Blood Loss/Bleeding8

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 21, 2024Difficult to Flush; Difficult to Flush

    IT WAS REPORTED THE FLUSHING PUMP HAD A FLUSHING ISSUE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19359309 ↗
  • MalfunctionApr 9, 2024Connection Problem; Connection Problem

    IT WAS REPORTED THE FLUSHING PUMP HEAD WAS NOT LATCHING. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19068860 ↗
  • MalfunctionApr 8, 2024Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED, THAT THE FLUSHING PUMP FOOT SWITCH HAD AIR LEAKAGE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A DIAGNOSTIC COLONOSCOPY PROCEDURE AND IT WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19063893 ↗
  • MalfunctionApr 5, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

    IT WAS REPORTED, THE SUBJECT DEVICE SWITCH BOARD IS OCCASIONALLY OUT OF ORDER (BUTTON SWITCH PART OF THE FRONT PANEL IS FAULTY). THE ISSUE WAS FOUND BEFORE A THERAPEUTIC COLONOSCOPY PROCEDURE, DURING CLEANING AND DISINFECTION.. THE PROCEDURE WAS DELAYED FOR AN UNSPECIFIED LENGTH OF TIME AND PATIENT WAS UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS COMPLETED USING ANOTHER METHOD: RINSED MANUALLY. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19050280 ↗
  • MalfunctionApr 4, 2024Restricted Flow rate; Key or Button Unresponsive/not Working; Restricted Flow rate; Key or Button Unresponsive/not Working

    IT WAS REPORTED, THE CONTROL BUTTONS OF THE SUBJECT DEVICE ARE ALMOST IMPOSSIBLE TO PRESS, AND IT ONLY PUMPS WEAKLY. THE ISSUE OCCURRED DURING PREPARATION FOR A DIAGNOSTIC COLONOSCOPY PROCEDURE THAT WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19042479 ↗
  • MalfunctionApr 3, 2024Activation Problem; Activation Problem

    IT WAS REPORTED, THE FLUSHING PUMP OFP-2 HAD FOOT SWITCH FAILURE. THE ISSUE OCCURRED DURING ARRIVAL ACCEPTANCE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19038161 ↗
  • MalfunctionApr 1, 2024Mechanics Altered; Mechanics Altered

    IT WAS REPORTED THAT THE FLUSHING PUMP FOOTSWITCH WAS DEFLATED AND COULD NOT BE RE-INFLATE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR USER INJURY ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19015008 ↗
  • MalfunctionApr 1, 2024Failure to Pump; Failure to Pump

    IT WAS REPORTED THE FLUSHING PUMP HAD A WATER TRANSMISSION MALFUNCTION WITH AN ARTIFICIAL WATER INJECTION TO ASSIST NORMAL COMPLETION OF A DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19014552 ↗
  • MalfunctionMar 29, 2024Activation Problem; Activation Problem

    IT WAS REPORTED THAT THE SUBJECT DEVICE HAD FOOT PEDAL FAILURE DURING CLEANING AND DISINFECTION. THERE WAS NO PATIENT INVOLVEMENT. NO REPORTS OF USER HARM ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19005196 ↗
  • MalfunctionMar 27, 2024Break; Break

    IT WAS REPORTED THE FLUSHING PUMP HAD A DEFECTIVE WATER SUPPLY DURING PRE-USE INSPECTION. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18986430 ↗
  • MalfunctionMar 13, 2024Positioning Problem; Positioning Problem

    IT WAS REPORTED THE FOOT SWITCH OF THE FLUSHING PUMP WOULD NOT GO TO THE HOME POSITION. THE REPORTED MALFUNCTION OCCURRED INTERMITTENTLY. THE REPORTED MALFUNCTION OCCURRED AT AN UNSPECIFIED TIME. THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18896015 ↗
  • MalfunctionMar 1, 2024Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED THAT THE PUMP HEAD DOES NOT CLOSE OVER THE TUBING. IT WAS ALSO REPORTED THAT THE PUMP HEAD HAD NEVER BEEN REPLACED AND WAS IN BAD SHAPE. THE PROCEDURE TO BE PERFORMED WAS DIAGNOSTIC IN NATURE AND WAS COMPLETED USING THE SAME EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18818251 ↗
  • MalfunctionOct 9, 2023Break; Break

    THE CUSTOMER REPORTED TO OLYMPUS, THE FLUSHING PUMP BROKE INTO THREE DIFFERENT PIECES. THE ISSUE WAS FOUND DURING A DIAGNOSTIC, COLONOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17892801 ↗
  • MalfunctionNov 22, 2022Break; Break

    THE OLYMPUS DEMO ASSET DEVICE WAS SENT IN FOR INSPECTION. THERE WAS NO PATIENT OR USER INJURY REPORTED. UPON INSPECTION AND TESTING, SERVICE FOUND THE RIGHT CASTOR WAS DAMAGED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15848221 ↗
  • MalfunctionMar 10, 2022Pressure Problem; Pressure Problem

    THE CUSTOMER REPORTED TO OLYMPUS, DURING ROUTINE SCREENING COLONOSCOPIES, WHEN IRRIGATING A THE CECUM, THE TISSUE STARTED TO BLEED. THE BLEEDING STOPPED ON ITS OWN. THE PUMP SETTING WAS ON 7-8 AND WAS TURNED TO 1 BUT THERE WAS STILL 'A BIT OF BLEEDING' LESS IRRIGATION WAS USED TOO AFTER THIS EVENT. THERE WAS APPROXIMATELY A 'COUPLE OF MINUTES' OF A DELAY IN PROCEDURE WHILE THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE. THIS ISSUE OCCURRED ON THE SAME DAY WITH A TOTAL OF 4 PATIENTS. THE CUSTOMER REPORTED, BY THE FOURTH PATIENT, THE PROCEDURE WAS STARTED WITH THE PUMP SETTINGS AT 1-2 AND IT 'WASN'T AS BAD.' TWO DAYS LATER, FOUR MORE COLONOSCOPIES WERE PERFORMED WITH A DIFFERENT SURGEON, KEEPING THE SETTINGS DOWN LOW AND THERE WERE NO ISSUES. ADDITIONAL PROCEDURES WERE PERFORMED THE FOLLOWING WEEK WITH THE FIRST SURGEON AND THERE WERE ALSO NO ISSUES. THE FACILITY STATED THEY ARE ADJUSTING THE PRESSURE PRIOR TO THE START AT EACH EXAM WITH EACH SCOPE. THE CUSTOMER CONFIRMED, TURNING DOWN THE FLOW RATE HELPED DECREASE THE INCIDENCE OF BLEEDING. THIS EVENT INCLUDES 4 REPORTS: (B)(6): 75YO, MALE, 219LBS, (B)(6): 61YO, FEMALE, 151LBS, (B)(6): 70YO, FEMALE, 250 LBS, (B)(6): 70YO MALE, 211

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 13723681 ↗
  • MalfunctionMar 10, 2022Pressure Problem; Pressure Problem

    THE CUSTOMER REPORTED TO OLYMPUS, DURING ROUTINE SCREENING COLONOSCOPIES, WHEN IRRIGATING A THE CECUM, THE TISSUE STARTED TO BLEED. THE BLEEDING STOPPED ON ITS OWN. THE PUMP SETTING WAS ON 7-8 AND WAS TURNED TO 1 BUT THERE WAS STILL 'A BIT OF BLEEDING' LESS IRRIGATION WAS USED TOO AFTER THIS EVENT. THERE WAS APPROXIMATELY A 'COUPLE OF MINUTES' OF A DELAY IN PROCEDURE WHILE THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE. THIS ISSUE OCCURRED ON THE SAME DAY WITH A TOTAL OF 4 PATIENTS. THE CUSTOMER REPORTED, BY THE FOURTH PATIENT, THE PROCEDURE WAS STARTED WITH THE PUMP SETTINGS AT 1-2 AND IT 'WASN'T AS BAD.' TWO DAYS LATER, FOUR MORE COLONOSCOPIES WERE PERFORMED WITH A DIFFERENT SURGEON, KEEPING THE SETTINGS DOWN LOW AND THERE WERE NO ISSUES. ADDITIONAL PROCEDURES WERE PERFORMED THE FOLLOWING WEEK WITH THE FIRST SURGEON AND THERE WERE ALSO NO ISSUES. THE FACILITY STATED THEY ARE ADJUSTING THE PRESSURE PRIOR TO THE START AT EACH EXAM WITH EACH SCOPE. THE CUSTOMER CONFIRMED, TURNING DOWN THE FLOW RATE HELPED DECREASE THE INCIDENCE OF BLEEDING. THIS EVENT INCLUDES 4 REPORTS: (B)(6): 75YO, MALE, 219LBS. (B)(6): 61YO, FEMALE, 151LBS. (B)(6): 70YO, FEMALE, 250 LBS. (B)(6): 70YO MALE, 211

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 13723669 ↗
  • MalfunctionMar 10, 2022Pressure Problem; Pressure Problem

    THE CUSTOMER REPORTED TO OLYMPUS, DURING ROUTINE SCREENING COLONOSCOPIES, WHEN IRRIGATING A THE CECUM, THE TISSUE STARTED TO BLEED. THE BLEEDING STOPPED ON ITS OWN. THE PUMP SETTING WAS ON 7-8 AND WAS TURNED TO 1 BUT THERE WAS STILL 'A BIT OF BLEEDING' LESS IRRIGATION WAS USED TOO AFTER THIS EVENT. THERE WAS APPROXIMATELY A 'COUPLE OF MINUTES' OF A DELAY IN PROCEDURE WHILE THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE. THIS ISSUE OCCURRED ON THE SAME DAY WITH A TOTAL OF 4 PATIENTS. THE CUSTOMER REPORTED, BY THE FOURTH PATIENT, THE PROCEDURE WAS STARTED WITH THE PUMP SETTINGS AT 1-2 AND IT 'WASN'T AS BAD.' TWO DAYS LATER, FOUR MORE COLONOSCOPIES WERE PERFORMED WITH A DIFFERENT SURGEON, KEEPING THE SETTINGS DOWN LOW AND THERE WERE NO ISSUES. ADDITIONAL PROCEDURES WERE PERFORMED THE FOLLOWING WEEK WITH THE FIRST SURGEON AND THERE WERE ALSO NO ISSUES. THE FACILITY STATED THEY ARE ADJUSTING THE PRESSURE PRIOR TO THE START AT EACH EXAM WITH EACH SCOPE. THE CUSTOMER CONFIRMED, TURNING DOWN THE FLOW RATE HELPED DECREASE THE INCIDENCE OF BLEEDING. THIS EVENT INCLUDES 4 REPORTS: (B)(6): 75YO, MALE, 219LBS. (B)(6): 61YO, FEMALE, 151LBS. (B)(6): 70YO, FEMALE, 250 LBS. (B)(6): 70YO MALE, 211

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 13723667 ↗
  • MalfunctionMar 10, 2022Pressure Problem; Pressure Problem

    THE CUSTOMER REPORTED TO OLYMPUS, DURING ROUTINE SCREENING COLONOSCOPIES, WHEN IRRIGATING A THE CECUM, THE TISSUE STARTED TO BLEED. THE BLEEDING STOPPED ON ITS OWN. THE PUMP SETTING WAS ON 7-8 AND WAS TURNED TO 1 BUT THERE WAS STILL 'A BIT OF BLEEDING' LESS IRRIGATION WAS USED TOO AFTER THIS EVENT. THERE WAS APPROXIMATELY A 'COUPLE OF MINUTES' OF A DELAY IN PROCEDURE WHILE THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE. THIS ISSUE OCCURRED ON THE SAME DAY WITH A TOTAL OF 4 PATIENTS. THE CUSTOMER REPORTED, BY THE FOURTH PATIENT, THE PROCEDURE WAS STARTED WITH THE PUMP SETTINGS AT 1-2 AND IT 'WASN'T AS BAD.' TWO DAYS LATER, FOUR MORE COLONOSCOPIES WERE PERFORMED WITH A DIFFERENT SURGEON, KEEPING THE SETTINGS DOWN LOW AND THERE WERE NO ISSUES. ADDITIONAL PROCEDURES WERE PERFORMED THE FOLLOWING WEEK WITH THE FIRST SURGEON AND THERE WERE ALSO NO ISSUES. THE FACILITY STATED THEY ARE ADJUSTING THE PRESSURE PRIOR TO THE START AT EACH EXAM WITH EACH SCOPE. THE CUSTOMER CONFIRMED, TURNING DOWN THE FLOW RATE HELPED DECREASE THE INCIDENCE OF BLEEDING. THIS EVENT INCLUDES 4 REPORTS: (B)(6): 75YO, MALE, 219LBS. (B)(6): 61YO, FEMALE, 151LBS. (B)(6): 70YO, FEMALE, 250 LBS. (B)(6): 70YO MALE, 211

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 13723635 ↗
  • MalfunctionMar 10, 2022Energy Output Problem

    THE CUSTOMER REPORTED TO OLYMPUS, DURING ROUTINE SCREENING COLONOSCOPIES, WHEN IRRIGATING A THE CECUM, THE TISSUE STARTED TO BLEED. THE BLEEDING STOPPED ON ITS OWN. THE PUMP SETTING WAS ON 7-8 AND WAS TURNED TO 1 BUT THERE WAS STILL 'A BIT OF BLEEDING' LESS IRRIGATION WAS USED TOO AFTER THIS EVENT. THERE WAS APPROXIMATELY A 'COUPLE OF MINUTES' OF A DELAY IN PROCEDURE WHILE THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE. THIS ISSUE OCCURRED ON THE SAME DAY WITH A TOTAL OF 4 PATIENTS. THE CUSTOMER REPORTED, BY THE FOURTH PATIENT, THE PROCEDURE WAS STARTED WITH THE PUMP SETTINGS AT 1-2 AND IT 'WASN'T AS BAD.' TWO DAYS LATER, FOUR MORE COLONOSCOPIES WERE PERFORMED WITH A DIFFERENT SURGEON, KEEPING THE SETTINGS DOWN LOW AND THERE WERE NO ISSUES. ADDITIONAL PROCEDURES WERE PERFORMED THE FOLLOWING WEEK WITH THE FIRST SURGEON AND THERE WERE ALSO NO ISSUES. THE FACILITY STATED THEY ARE ADJUSTING THE PRESSURE PRIOR TO THE START AT EACH EXAM WITH EACH SCOPE. THE CUSTOMER CONFIRMED, TURNING DOWN THE FLOW RATE HELPED DECREASE THE INCIDENCE OF BLEEDING. THIS EVENT INCLUDES 4 REPORTS: (B)(6): (B)(6), MALE, (B)(6) LBS (B)(6): (B)(6), FEMALE, (B)(6) LBS (B)(6): (B)(6), FEMALE, (B)(6) LBS, (B)(6):

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 13722903 ↗
  • MalfunctionMar 10, 2022Energy Output Problem

    THE CUSTOMER REPORTED TO OLYMPUS, DURING ROUTINE SCREENING COLONOSCOPIES, WHEN IRRIGATING A THE CECUM, THE TISSUE STARTED TO BLEED. THE BLEEDING STOPPED ON ITS OWN. THE PUMP SETTING WAS ON 7-8 AND WAS TURNED TO 1 BUT THERE WAS STILL 'A BIT OF BLEEDING' LESS IRRIGATION WAS USED TOO AFTER THIS EVENT. THERE WAS APPROXIMATELY A 'COUPLE OF MINUTES' OF A DELAY IN PROCEDURE WHILE THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE. THIS ISSUE OCCURRED ON THE SAME DAY WITH A TOTAL OF 4 PATIENTS. THE CUSTOMER REPORTED, BY THE FOURTH PATIENT, THE PROCEDURE WAS STARTED WITH THE PUMP SETTINGS AT 1-2 AND IT 'WASN'T AS BAD.' TWO DAYS LATER, FOUR MORE COLONOSCOPIES WERE PERFORMED WITH A DIFFERENT SURGEON, KEEPING THE SETTINGS DOWN LOW AND THERE WERE NO ISSUES. ADDITIONAL PROCEDURES WERE PERFORMED THE FOLLOWING WEEK WITH THE FIRST SURGEON AND THERE WERE ALSO NO ISSUES. THE FACILITY STATED THEY ARE ADJUSTING THE PRESSURE PRIOR TO THE START AT EACH EXAM WITH EACH SCOPE. THE CUSTOMER CONFIRMED, TURNING DOWN THE FLOW RATE HELPED DECREASE THE INCIDENCE OF BLEEDING. THIS EVENT INCLUDES 4 REPORTS: (B)(6). THIS IS REPORT 2 OF 4 FOR (B)(6).: (B)(6) YO, FEMALE, (B)(6).LBS.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 13722892 ↗
  • MalfunctionMar 10, 2022Energy Output Problem

    THE CUSTOMER REPORTED TO OLYMPUS, DURING ROUTINE SCREENING COLONOSCOPIES, WHEN IRRIGATING A THE CECUM, THE TISSUE STARTED TO BLEED. THE BLEEDING STOPPED ON ITS OWN. THE PUMP SETTING WAS ON 7-8 AND WAS TURNED TO 1 BUT THERE WAS STILL 'A BIT OF BLEEDING' LESS IRRIGATION WAS USED TOO AFTER THIS EVENT. THERE WAS APPROXIMATELY A 'COUPLE OF MINUTES' OF A DELAY IN PROCEDURE WHILE THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE. THIS ISSUE OCCURRED ON THE SAME DAY WITH A TOTAL OF 4 PATIENTS. THE CUSTOMER REPORTED, BY THE FOURTH PATIENT, THE PROCEDURE WAS STARTED WITH THE PUMP SETTINGS AT 1-2 AND IT 'WASN'T AS BAD.' TWO DAYS LATER, FOUR MORE COLONOSCOPIES WERE PERFORMED WITH A DIFFERENT SURGEON, KEEPING THE SETTINGS DOWN LOW AND THERE WERE NO ISSUES. ADDITIONAL PROCEDURES WERE PERFORMED THE FOLLOWING WEEK WITH THE FIRST SURGEON AND THERE WERE ALSO NO ISSUES. THE FACILITY STATED THEY ARE ADJUSTING THE PRESSURE PRIOR TO THE START AT EACH EXAM WITH EACH SCOPE. THE CUSTOMER CONFIRMED, TURNING DOWN THE FLOW RATE HELPED DECREASE THE INCIDENCE OF BLEEDING. THIS EVENT INCLUDES 4 REPORTS: B)(6): (B)(6) MALE, (B)(6). B)(6): (B)(6) FEMALE, (B)(6). B)(6): (B)(6) FEMALE, (B)(6). (B)(6): (B)(6) MALE, (B)

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 13722867 ↗
  • MalfunctionMar 10, 2022Energy Output Problem

    THE CUSTOMER REPORTED TO OLYMPUS, DURING ROUTINE SCREENING COLONOSCOPIES, WHEN IRRIGATING A THE CECUM, THE TISSUE STARTED TO BLEED. THE BLEEDING STOPPED ON ITS OWN. THE PUMP SETTING WAS ON 7-8 AND WAS TURNED TO 1 BUT THERE WAS STILL 'A BIT OF BLEEDING' LESS IRRIGATION WAS USED TOO AFTER THIS EVENT. THERE WAS APPROXIMATELY A 'COUPLE OF MINUTES' OF A DELAY IN PROCEDURE WHILE THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE. THIS ISSUE OCCURRED ON THE SAME DAY WITH A TOTAL OF 4 PATIENTS. THE CUSTOMER REPORTED, BY THE FOURTH PATIENT, THE PROCEDURE WAS STARTED WITH THE PUMP SETTINGS AT 1-2 AND IT 'WASN'T AS BAD.' TWO DAYS LATER, FOUR MORE COLONOSCOPIES WERE PERFORMED WITH A DIFFERENT SURGEON, KEEPING THE SETTINGS DOWN LOW AND THERE WERE NO ISSUES. ADDITIONAL PROCEDURES WERE PERFORMED THE FOLLOWING WEEK WITH THE FIRST SURGEON AND THERE WERE ALSO NO ISSUES. THE FACILITY STATED THEY ARE ADJUSTING THE PRESSURE PRIOR TO THE START AT EACH EXAM WITH EACH SCOPE. THE CUSTOMER CONFIRMED, TURNING DOWN THE FLOW RATE HELPED DECREASE THE INCIDENCE OF BLEEDING. THIS EVENT INCLUDES 4 REPORTS: (B)(6): 75YO, MALE, 219LBS, (B)(6) : 61YO, FEMALE, 151LBS, (B)(6) : 70YO, FEMALE, 250LB, (B)(6) : 70YO MALE, 211

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 13722845 ↗

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