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 Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

It was reported, the flushing pump footing pedal did not return to its original position when the pedal was pressed and released, so even pressing the pedal had no effect.This issue occurred during preparation for use.There were no reports of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: b3, d4, d8, d9, h2, h3, h4, h6, h10 correction: b5 e2: health professional ¿ (blank) e3: occupation ¿ no information provided.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was inspected for on-site repair and the reported failure was confirmed.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: mechanical failure of foot switch.Olympus will continue to monitor field performance for this device.

Event Description

It was reported, the flushing pump footing pedal did not return to its original position when the pedal was pressed and released, even pressing the pedal had no effect.This issue occurred during preparation for use.There were no reports of patient harm.

• 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: 18832918
• MDR Text Key: 337320083
• Report Number: 9611174-2024-01024
• Device Sequence Number: 1
• Product Code: FEQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K100899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K10001145
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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