Supplementals

When is a supplemental report needed? Múltiple choice

• New information has been received and it changes the reportability

• Investigation has finished and the results are available

• To do corrections of the initial report.

FSE stands for

• Formal service employee

• Foreign service engineer

• Field service engineer

When a device is evaluated by an FSE?

• When the device was returned and evaluated by the LM

• When an engineer is dispatched to the user facility to evaluate and/or repair the device.

• when troubleshooting is performed with an Olympus representative on the phone.

How is D9 filled when FSE evaluated the device?

• No

• Yes, without receipt date

• Yes, with receipt date

In H2 for a supplemental report, you can select only one option. True or false?

• False

• True

For type of investigation code we are going to use B-14 analysis of production records (DHR) when:

• The lot/serial number is unknown

• The lot/serial Number is known and DHR is confirmed

• When the DHR is not confirmed.

For a reportable malfunction with new findings the additional assesment “new information aware date” should:

• Be updated to the “approved date” from the investigation.

• Be updated to “approved date” from the evaluation.

• Not be updated.