TPLC - Total Product Life Cycle

• Device: cannula, surgical, general & plastic surgery
• Product Code: GEA
• Regulation Number: 878.4800
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2017	46	46
2018	58	58
2019	62	62
2020	158	158
2021	149	149
2022	83	83

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Markings/Labelling Problem	118	118
Break	111	111
Device-Device Incompatibility	65	65
Adverse Event Without Identified Device or Use Problem	50	50
Delivered as Unsterile Product	37	37
Crack	23	23
Material Deformation	16	16
Fluid/Blood Leak	15	15
Contamination /Decontamination Problem	12	12
Tear, Rip or Hole in Device Packaging	12	12
Detachment of Device or Device Component	11	11
Material Separation	10	10
Material Twisted/Bent	8	8
Mechanical Jam	8	8
Material Fragmentation	7	7
Device Contamination with Chemical or Other Material	7	7
Entrapment of Device	6	6
Appropriate Term/Code Not Available	5	5
Device Contaminated During Manufacture or Shipping	5	5
Physical Resistance/Sticking	5	5
Fracture	3	3
Insufficient Information	3	3
Temperature Problem	2	2
Device Dislodged or Dislocated	2	2
Material Puncture/Hole	2	2
Device Slipped	2	2
Patient-Device Incompatibility	2	2
Device Operates Differently Than Expected	2	2
Material Integrity Problem	2	2
Detachment Of Device Component	2	2
Contamination	2	2
Leak/Splash	2	2
Defective Component	1	1
Solder Joint Fracture	1	1
Device Contamination With Biological Material	1	1
Missing Information	1	1
Partial Blockage	1	1
Device Handling Problem	1	1
Component or Accessory Incompatibility	1	1
Out-Of-Box Failure	1	1
Incomplete or Missing Packaging	1	1
Burst Container or Vessel	1	1
Migration or Expulsion of Device	1	1
Unsealed Device Packaging	1	1
Use of Device Problem	1	1
Failure to Align	1	1
Melted	1	1
Nonstandard Device	1	1
Improper Flow or Infusion	1	1
Inadequate User Interface	1	1
Packaging Problem	1	1
No Apparent Adverse Event	1	1
Difficult to Open or Close	1	1
Loss of or Failure to Bond	1	1
Material Erosion	1	1
Material Rupture	1	1
Device Damaged Prior to Use	1	1
Connection Problem	1	1
Complete Loss of Power	1	1
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	218	218
No Consequences Or Impact To Patient	206	206
No Known Impact Or Consequence To Patient	36	36
Not Applicable	29	29
Abscess	20	20
Foreign Body In Patient	15	15
No Code Available	14	14
No Patient Involvement	14	14
Unspecified Infection	12	12
Post Operative Wound Infection	9	9
Obstruction/Occlusion	9	9
Pain	8	8
Blood Loss	7	7
Hernia	7	7
Seroma	7	7
Hematoma	6	6
Inflammation	5	5
Insufficient Information	5	5
Fever	5	5
Device Embedded In Tissue or Plaque	5	5
Hemorrhage/Bleeding	4	4
No Information	3	3
Failure to Anastomose	3	3
Sepsis	3	3
Wound Dehiscence	3	3
Needle Stick/Puncture	2	2
Vomiting	2	2
Burn(s)	2	2
Peritonitis	2	2
Necrosis	2	2
Abdominal Pain	2	2
Bradycardia	1	1
Cellulitis	1	1
Ectopic Pregnancy	1	1
Edema	1	1
Nausea	1	1
Thromboembolism	1	1
Swelling/ Edema	1	1
Unintended Radiation Exposure	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Low Blood Pressure/ Hypotension	1	1
Infection, Pyrogenic	1	1
Injury	1	1
Premature Labor	1	1
Pleural Effusion	1	1
Pneumothorax	1	1
Tachycardia	1	1
Adhesion(s)	1	1
Purulent Discharge	1	1
Fistula	1	1
Incontinence	1	1
Cardiac Tamponade	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CLINICAL LASERTHERMIA SYSTEMS AB	II	Jun-04-2021
2	Cardinal Health 200, LLC	II	Mar-09-2020
3	Genicon, Inc.	II	Jun-05-2020
4	TeDan Surgical Innovations LLC	II	May-01-2020