Reportable Type (potential fragment, unclamping, arcing, or unintuitive motion)
Instrument has physical damage during a procedure, FFIP = Not Applicable or Unknown.
What is potential fragment risk?
What is PR=No/ Not Reportable
Broken gears. FFIP = No.
What is "Physical Damage - No Fragment Fall"?
Broken input disks discovered during central processing. FFIP = No.
What is an example of no follow-up required?
Complaints will be escalated to this team if the CRM notes mention bleeding, burns, or a conversion to open surgery.
Who is the Adverse Events team?
Force Bipolar with misaligned/ bent grips
What is potential unclamping/ tissue entrapment?
What is PR=Yes/ Reportable?
Scope won't flip.
What is "Image Orientation Issue"?
"Broken Cable." Material number = 470171-13.
What is follow-up required for potential arcing?
This team will support Mexicali with simple customer follow-up on non-reportable complaints.
Who is Peachtree Corners/ who is PTC?
Black cable sticking out
What is potential arcing?
CRM Notes: Jaws of the Force Bipolar were stuck shut prior to start. IRK didn't work, sending it back.
What is PR=Yes/ Reportable?
Black cable sticking out.
What is "Cautery Issue-Broken/Loose Cautery Wire"?
Force Bipolar with bent grips. No missing critical fields.
What is follow-up required for potential unclamping/ tissue entrapment issue?
Non-reportable complaints will be "Assigned To" this person while they are pending completion of customer follow-up.
Who is Gama?
The image just looks wrong
What is potential unintuitive motion (inverted image) risk?
CRM Notes: Loose black cable
What is PR=Yes / Not Reportable?
EOL
What is "Out of Uses/ Expired Prematurely"?
IDK the endoscope just doesn't work. All critical fields blank/ unknown.
What is follow-up required for unintuitive motion (inverted image) AND potential fragment?
This is the combination of "potential reportability" and "follow-up requirements" that can be retained by the Mexicali team if the complaint originated in Spain.
What is a PR=No case that does not require follow-up?
Had to use the IRK
CRM Notes: just a little tear in the clear part of the tip cover, no arcing.
What is PR=Yes/ Not Reportable?
Failed self-check.
What is "Calibration"?
Broke during the procedure. Identified when = During Procedure. Procedure Outcome = Unknown. FFIP = unknown.
What is follow-up required for insufficient information + critical patient fields/ patient involvement/ patient harm?
The complaint owner and the follow up assignee for these CRM notes: "The Force Bipolar instrument looked like the jaws were unhinged/ dislodged." The country of origin is Japan.
Who is Melody + Not Me (either Melody or the OUS follow-up assignee already assigned)?