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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 Problem Pressure Problem (3012)
Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)
Event Date 09/04/2020
Event Type  Injury  
Manufacturer Narrative
The device was returned to olympus for evaluation. Based on the initial evaluation of the device, there was no problem found on the device, as the device worked appropriately after testing for 30 minutes. No conclusion can be drawn at this time, as the investigation is still ongoing. If new and significant information becomes available at a later time, this report will be supplemented.
 
Event Description
It was reported that during a therapeutic colonoscopy with polypectomy using the endoscopic mucosa dissection technique the physician documented "2 small defects in the muscularis propria observed with no full perforation. " physician documented "tissue edges approximated and 11 clips were placed. " the polyp being removed was reported to be 40mm in size and was found in the ascending colon. The device failed to provide enough water pressure/intensity to lift the lesion; therefore, the physician had to switch the technique to endoscopic mucosal resection (emr) and remove the lesion in the "piecemeal" technique. The patient was discharged home on (b)(6) 2020 after being admitted for the procedure. She had to undergo surgery after experiencing abdominal pain the day after the procedure, and underwent an exploratory laparotomy and a right hemicolectomy. Patient was discharged home with a wound vac.
 
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Brand NameFLUSHING PUMP OFP-2 (US)
Type of DeviceOLYMPUS 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
Manufacturer Contact
alison prior
keymed house, stock road
southend on sea, essex SS25Q-H
UK   SS25QH
0441702616
MDR Report Key10781904
MDR Text Key214795322
Report Number9611174-2020-00037
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
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberK10001141
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/27/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/03/2020 Patient Sequence Number: 1
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