MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. FLUSHING PUMP OFP-2 (US); OLYMPUS FLUSHING PUMP

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.

Manufacturer Narrative

This report is being supplemented to provide the final results of the investigation.No device was forwarded to the legal manufacturer, as the evaluation did not find any problems with the device; the device tested and passed all functional and measurable tests.The device has been returned to the customer.

• 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 Key: 10781904
• MDR Text Key: 214795322
• Report Number: 9611174-2020-00037
• Device Sequence Number: 1
• Product Code: FEQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• 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 Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: K10001141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 71