GCHS first quiz

"The customer reported that during a therapeutic laparoscopy, the video center exhibits a B30 error and then the imagen gone black. There was no patient harm."

According to previous statement, how many RADs do you identify?

• 1

• 2

• 3

• 4

Global US MDR Team Representative who is responsible for assessing 
complaints to determine US MDR reportability for product malfunctions, 
drafting and submitting MDR malfunction reports in a timely manner per 
US MDR regulations.

Is this a responsibility of the Analysts II?

• True

• False

If there is a complaint with a concomitant device, which date would be used when you add the device in D10?

• Notification date

• Event date

• Aware date

• Manufacturing date

The customer allegation was reported during the reprocessing, and we do not have any information regarding the patient. Which null value is applicable in this case?

• NI

• NA

• ASKU

If there is complaint from Japan, it is correct to fill the Zip code field.

• True

• False

If we have a case in which the device is a single-used device, which section should be filled?

• Lot #

• Serial #

In H6, if the event reported that the malfunction occurred during a procedure, which code should be used in Health effect-Health impact?

• F26

• F27

The issue reported by the customer said: "There was a leakage from the biopsy channel in a gastroscopic endoscope."

Which code is the more accurate to be used in the component code in H6?

• G05003 - Endoscope

• G04001 - Instrument channel

The complaint states that during the procedure, there was a delay of 20 minutes. Besides this information, the assessment can be done as normal, and so the EMDR.

• True

• False

If we have two different serial number, one in the description and the other in the product field. Which should be your behavior?

• Use the one in the description for drafting the EMDR.

• Use the one in the product field for drafting the EMDR.

• Create an action before EMDR completion.

• Complete EMDR and after that, create an action.