MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; STEM IMPACTOR INSTRUMENT

Model Number SI-7501E-03N

Device Problems Component Missing (2306); No Apparent Adverse Event (3189)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

An instrument was found to be damaged by a sales representative.It is not known if the instrument was involved in a surgery when it was damaged or if it caused an adverse event for a patient.The device has not been returned at this time.A capa has been initiated for this issue.When more information is available, a supplement report will be submitted.

Event Description

A sales representative found an instrument that was disassembled.It is not known if the damage occured during a surgery or if it negatively affected a patient.If more information is discovered, a supplement report will be submitted.

Manufacturer Narrative

Capa determined that the design of the device was the likely root cause of the failure.A change is in process to correct the issue.

Event Description

There are still no reported harms to patients that have occured due to this failure.

• Brand Name: ELEOS
• Type of Device: STEM IMPACTOR INSTRUMENT
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11671281
• MDR Text Key: 247918535
• Report Number: 3013450937-2021-00040
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278SI7501E03N0
• UDI-Public: B278SI7501E03N0
• Combination Product (y/n): N
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SI-7501E-03N
• Device Catalogue Number: SI-7501E-03N
• Device Lot Number: 87424
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1