TPLC - Total Product Life Cycle

• Device: forceps, obstetrical
• Regulation Description: Obstetric forceps.
• Product Code: HDA
• Regulation Number: 884.4400
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2021	21	21
2022	13	13
2023	30	30
2024	14	14
2025	9	9
2026	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	50	50
Detachment of Device or Device Component	49	49
Mechanical Problem	11	11
Difficult to Open or Close	10	10
Difficult to Remove	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Physical Resistance/Sticking	4	4
Failure to Align	3	3
Material Twisted/Bent	3	3
Material Split, Cut or Torn	2	2
Entrapment of Device	2	2
Mechanics Altered	2	2
Product Quality Problem	2	2
Insufficient Information	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Difficult to Insert	1	1
Material Protrusion/Extrusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	76	76
Unintended Radiation Exposure	9	9
Foreign Body In Patient	7	7
Insufficient Information	7	7
Unspecified Tissue Injury	3	3
Abdominal Pain	2	2
Syncope/Fainting	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Emotional Changes	2	2
Nausea	2	2
Abnormal Vaginal Discharge	2	2
Hematuria	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Erythema	2	2
Discomfort	2	2
Pain	2	2
Fluid Discharge	2	2
Constipation	2	2
Sleep Dysfunction	1	1
Dysuria	1	1
Dizziness	1	1
Muscle Weakness	1	1
Purulent Discharge	1	1
Cellulitis	1	1
Anxiety	1	1
Hemorrhage/Bleeding	1	1
Device Embedded In Tissue or Plaque	1	1