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

Model Number K10001145

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2024

Event Type  malfunction  

Event Description

It was reported, the front panel of flushing pump is not working.The issue occurred during preparation prior to a diagnostic gastroscopy.The procedure was completed using a similar device.There were no reports of patient harm.

Manufacturer Narrative

The device was returned, and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: FLUSHING PUMP OFP-2 (ROW)
• Type of Device: OLYMPUS FLUSHING PUMP
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend on sea, essex SS25Q H; UK SS25QH
• Manufacturer (Section G): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend on sea, essex SS25Q H; UK SS25QH
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18858936
• MDR Text Key: 337213327
• Report Number: 9611174-2024-01031
• Device Sequence Number: 1
• Product Code: FEQ
• UDI-Device Identifier: 15019778003238
• UDI-Public: 15019778003238
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K100899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/07/2024

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
• Device Operator: Health Professional
• Device Model Number: K10001145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CLV-290SL LIGHT SOURCE SN: (B)(6) ; CV-290 PROCESSOR SN: (B)(6)