TPLC - Total Product Life Cycle

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Device	stapler, surgical
Regulation Description	Surgical stapler.
Definition	A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
Product Code	GAG
Regulation Number	878.4740
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Fire	355	355
Failure to Form Staple	294	294
Adverse Event Without Identified Device or Use Problem	210	210
Detachment of Device or Device Component	168	168
Misfire	148	148
Mechanics Altered	107	107
Break	85	85
Difficult to Remove	85	85
Failure to Align	48	48
Human-Device Interface Problem	36	36
Failure to Cut	32	32
Loss of or Failure to Bond	30	30
Incomplete or Inadequate Connection	24	24
Material Twisted/Bent	24	24
Entrapment of Device	23	23
Insufficient Information	23	23
Device Slipped	22	22
Difficult to Open or Close	22	22
Retraction Problem	19	19
Expulsion	18	18
Firing Problem	17	17
Noise, Audible	16	16
Mechanical Problem	15	15
Mechanical Jam	14	14
Physical Resistance/Sticking	12	12
Protective Measures Problem	11	11
Product Quality Problem	10	10
Fail-Safe Problem	9	9
Device Appears to Trigger Rejection	9	9
Patient Device Interaction Problem	8	8
Therapeutic or Diagnostic Output Failure	8	8
Positioning Problem	7	7
Defective Device	7	7
Component or Accessory Incompatibility	6	6
Component Missing	4	4
Misassembly by Users	4	4
Packaging Problem	3	3
Failure to Cycle	3	3
No Device Output	3	3
Use of Device Problem	2	2
Difficult to Insert	2	2
Material Separation	2	2
Tear, Rip or Hole in Device Packaging	2	2
Improper or Incorrect Procedure or Method	2	2
Activation, Positioning or Separation Problem	2	2
Leak/Splash	2	2
Device Difficult to Setup or Prepare	1	1
Unraveled Material	1	1
Delivered as Unsterile Product	1	1
Ejection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	768	768
Tissue Breakdown	348	348
Failure to Anastomose	345	345
Insufficient Information	152	152
Hemorrhage/Bleeding	67	67
Unspecified Tissue Injury	47	47
Laceration(s)	38	38
Wound Dehiscence	34	34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	29	29
Adhesion(s)	23	23
Pain	22	22
Ascites	20	20
Inflammation	19	19
Abscess	16	16
Unspecified Infection	15	15
Fluid Discharge	15	15
Sepsis	15	15
Unintended Radiation Exposure	13	13
Abdominal Pain	12	12
Emotional Changes	12	12
Hematoma	11	11
Swelling/ Edema	10	10
Distress	9	9
Fistula	9	9
Peritonitis	9	9
No Known Impact Or Consequence To Patient	9	9
Fever	9	9
Impaired Healing	8	8
Muscle Weakness	8	8
Abdominal Distention	8	8
Nausea	8	8
Electrolyte Imbalance	8	8
Bowel Perforation	7	7
Deformity/ Disfigurement	7	7
Shock	7	7
Renal Failure	7	7
Anemia	7	7
Hernia	7	7
Septic Shock	7	7
Post Operative Wound Infection	7	7
Rectal Anastomotic Leakage	6	6
Skin Inflammation/ Irritation	6	6
Vomiting	6	6
Low Blood Pressure/ Hypotension	6	6
Anxiety	5	5
Stenosis	5	5
Organ Dehiscence	5	5
Tachycardia	5	5
Purulent Discharge	5	5
Obstruction/Occlusion	5	5