MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. FLUSHING PUMP OFP-2 (US); PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Model Number	K10001141
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
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 lbs.This is report 1 of 4 for (b)(6) : 75yo, male, 219lbs.

• Brand Name: FLUSHING PUMP OFP-2 (US)
• Common Device Name: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• 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 Key: 13722845
• Report Number: 2951238-2022-00349
• Device Sequence Number: 4142650
• Product Code: FEQ
• UDI-Device Identifier: 15019778003191
• UDI-Public: 15019778003191
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/10/2022
• Report Date (Section F): 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: K10001141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MAJ-2207, K10035002, UNKNOWN ENDOSCOPE
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 99 KG