TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Open or Close	85	85
Adverse Event Without Identified Device or Use Problem	82	82
Break	26	26
Failure to Cut	23	23
Dull, Blunt	20	20
Device Contamination with Chemical or Other Material	16	16
Material Twisted/Bent	16	16
Mechanical Problem	14	14
Use of Device Problem	12	12
Physical Resistance/Sticking	10	10
Insufficient Information	8	8
Human-Device Interface Problem	8	8
Difficult to Remove	8	8
Device Contaminated During Manufacture or Shipping	7	7
Mechanical Jam	6	6
Entrapment of Device	6	6
Appropriate Term/Code Not Available	6	6
Material Protrusion/Extrusion	5	5
Detachment of Device or Device Component	5	5
Delivered as Unsterile Product	5	5
Device Damaged Prior to Use	3	3
Material Deformation	3	3
Shipping Damage or Problem	3	3
Retraction Problem	2	2
Material Fragmentation	2	2
Material Integrity Problem	2	2
Unsealed Device Packaging	2	2
Stretched	1	1
Component Missing	1	1
Difficult to Insert	1	1
Structural Problem	1	1
Device Damaged by Another Device	1	1
Mechanics Altered	1	1
Degraded	1	1
Misassembled	1	1
Contamination	1	1
Failure to Clean Adequately	1	1
Product Quality Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Separation	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Device	1	1
Activation Failure	1	1
Failure to Advance	1	1
Device Dislodged or Dislocated	1	1
Device Reprocessing Problem	1	1
Wrong Label	1	1
Difficult to Advance	1	1
Improper or Incorrect Procedure or Method	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	127	127
Hemorrhage/Bleeding	43	43
No Known Impact Or Consequence To Patient	39	39
No Consequences Or Impact To Patient	29	29
Pancreatitis	15	15
Insufficient Information	15	15
Unspecified Tissue Injury	13	13
Tissue Damage	10	10
Hematoma	10	10
Unspecified Hepatic or Biliary Problem	9	9
Foreign Body In Patient	8	8
Perforation	7	7
Blood Loss	7	7
Hematuria	6	6
No Patient Involvement	5	5
Excessive Tear Production	4	4
Renal Failure	3	3
Urinary Tract Infection	3	3
Pneumothorax	3	3
Laceration(s)	3	3
Dysuria	3	3
No Code Available	3	3
Inflammation	3	3
Pneumonia	2	2
Vomiting	2	2
Urinary Retention	2	2
Septic Shock	2	2
Unspecified Mental, Emotional or Behavioural Problem	2	2
Fever	2	2
Cramp(s) /Muscle Spasm(s)	2	2
No Information	2	2
Fistula	2	2
Sepsis	2	2
Death	2	2
Liver Failure	2	2
Device Embedded In Tissue or Plaque	2	2
Abdominal Pain	2	2
Atrial Flutter	1	1
Pulmonary Embolism	1	1
Bruise/Contusion	1	1
Swelling/ Edema	1	1
Tachycardia	1	1
Heart Failure/Congestive Heart Failure	1	1
Dyspnea	1	1
Discomfort	1	1
Micturition Urgency	1	1
Chest Pain	1	1
Angina	1	1
Cardiac Arrest	1	1
Urinary Incontinence	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Richard Wolf GmbH	II	Apr-24-2023