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 02/01/2024

Event Type  malfunction  

Event Description

It was reported, the subject device had a foot switch malfunction.The issue occurred during preparation for use for a diagnostic gastroscopy procedure that was completed using same set of equipment.There were no reports of patient injury or harm associated with this event.

Manufacturer Narrative

E1: full facility name: (b)(6) hospital.The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was not returned to olympus for evaluation, but it was inspected for on-site repair.The customer's allegation was confirmed: the foot switch failure and flushing pump has poor water supply.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: the flushing pump event was caused by a component failure of pump head, and the foot switch failure event is caused by a mechanical failure of foot switch.A device history record review was conducted, and no issues were identified.Olympus will continue to monitor field performance for this device.

Event Description

It was reported, the subject device had a foot switch malfunction.The issue occurred during preparation for use for a diagnostic gastroscopy procedure that was completed using same set of equipment.There were no reports of patient injury or harm associated with this event.

• 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: 18816164
• MDR Text Key: 337440933
• Report Number: 9611174-2024-01017
• Device Sequence Number: 1
• Product Code: FEQ
• UDI-Device Identifier: 15019778003238
• UDI-Public: 15019778003238
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/16/2024
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2018
• 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: GIF-HQ290