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	82	82
Adverse Event Without Identified Device or Use Problem	76	76
Break	24	24
Failure to Cut	22	22
Dull, Blunt	18	18
Material Twisted/Bent	16	16
Device Contamination with Chemical or Other Material	15	15
Mechanical Problem	14	14
Physical Resistance/Sticking	10	10
Use of Device Problem	10	10
Difficult to Remove	8	8
Human-Device Interface Problem	8	8
Device Contaminated During Manufacture or Shipping	7	7
Insufficient Information	7	7
Mechanical Jam	6	6
Appropriate Term/Code Not Available	6	6
Delivered as Unsterile Product	5	5
Material Protrusion/Extrusion	5	5
Detachment of Device or Device Component	5	5
Entrapment of Device	5	5
Device Damaged Prior to Use	3	3
Shipping Damage or Problem	3	3
Retraction Problem	2	2
Material Integrity Problem	2	2
Material Fragmentation	2	2
Unsealed Device Packaging	2	2
Material Deformation	2	2
Wrong Label	1	1
Material Separation	1	1
Device Damaged by Another Device	1	1
Difficult to Insert	1	1
Mechanics Altered	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Device	1	1
Stretched	1	1
Contamination	1	1
Improper or Incorrect Procedure or Method	1	1
Failure to Advance	1	1
Product Quality Problem	1	1
Device Reprocessing Problem	1	1
Component Missing	1	1
Structural Problem	1	1
Deformation Due to Compressive Stress	1	1
Device Dislodged or Dislocated	1	1
Activation, Positioning or Separation Problem	1	1
Material Split, Cut or Torn	1	1
Therapeutic or Diagnostic Output Failure	1	1
Degraded	1	1
Activation Failure	1	1
Misassembled	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	118	118
No Known Impact Or Consequence To Patient	39	39
Hemorrhage/Bleeding	36	36
No Consequences Or Impact To Patient	29	29
Insufficient Information	14	14
Pancreatitis	14	14
Unspecified Tissue Injury	12	12
Tissue Damage	10	10
Hematoma	10	10
Unspecified Hepatic or Biliary Problem	9	9
Foreign Body In Patient	8	8
Blood Loss	7	7
Hematuria	6	6
No Patient Involvement	5	5
Perforation	5	5
Excessive Tear Production	4	4
Dysuria	3	3
Urinary Tract Infection	3	3
Pneumothorax	3	3
Renal Failure	3	3
Inflammation	3	3
No Code Available	3	3
Unspecified Mental, Emotional or Behavioural Problem	2	2
Liver Failure	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Pneumonia	2	2
Abdominal Pain	2	2
Death	2	2
Fever	2	2
Fistula	2	2
Vomiting	2	2
Urinary Retention	2	2
Device Embedded In Tissue or Plaque	2	2
No Information	2	2
Discomfort	1	1
Sepsis	1	1
Septic Shock	1	1
Tachycardia	1	1
Micturition Urgency	1	1
Dyspnea	1	1
Air Embolism	1	1
Angina	1	1
Atrial Flutter	1	1
Bruise/Contusion	1	1
Chest Pain	1	1
Laceration(s)	1	1
Pulmonary Embolism	1	1
Unspecified Infection	1	1
Urinary Incontinence	1	1
Swelling/ Edema	1	1
Heart Failure/Congestive Heart Failure	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

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