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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. FLUSHING PUMP OFP-2 (US); OLYMPUS FLUSHING PUMP
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KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. FLUSHING PUMP OFP-2 (US); OLYMPUS FLUSHING PUMP Back to Search Results
Model Number K10001141
Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Patient Problem Fall (1848)
Event Date 07/05/2022
Event Type  Injury  
Event Description
The customer reports during a colonoscopy procedure using auxiliary water tubing attached to a flushing pump and a scope, somehow the tubing became disconnected from the auxiliary water inlet on the scope.The user did not notice this issue and the user kept on activating the flushing pump, leaking approximately one gallon of water onto the flooring.The nurse did not notice the wet floor, and fell on her tailbone.The nurse was taken to the emergency room for evaluation and x-rays were taken to ensure there were no fractures.The nurse missed work due to this occurrence.No further consequences to the nurse have been reported.The user finished up the colonoscopy case.There was no impact to the patient as a result of this occurrence.The suspect device was returned to olympus.The user's report of the pump blowing off the tubing was not confirmed during inspection/evaluation.
 
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Brand Name
FLUSHING PUMP OFP-2 (US)
Type of Device
OLYMPUS FLUSHING PUMP
Manufacturer (Section D)
KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
keymed house, stock road
southend-on-sea, essex SS2 5 QH
UK  SS2 5QH
MDR Report Key15148397
MDR Text Key297079155
Report Number2429304-2022-00011
Device Sequence Number1
Product Code FEQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 07/05/2022,08/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberK10001141
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2022
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date07/05/2022
Event Location Hospital
Date Report to Manufacturer07/05/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COLONOSCOPE AND TUBING
Patient Outcome(s) Other;
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