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	514	514
Failure to Form Staple	443	443
Adverse Event Without Identified Device or Use Problem	323	325
Detachment of Device or Device Component	252	252
Misfire	230	231
Mechanics Altered	152	152
Difficult to Remove	134	134
Break	117	117
Failure to Align	71	71
Human-Device Interface Problem	60	60
Failure to Cut	48	48
Incomplete or Inadequate Connection	46	46
Device Slipped	35	35
Retraction Problem	33	33
Material Twisted/Bent	33	33
Insufficient Information	32	32
Entrapment of Device	30	30
Loss of or Failure to Bond	29	29
Difficult to Open or Close	24	24
Firing Problem	23	23
Noise, Audible	18	18
Expulsion	18	18
Protective Measures Problem	18	18
Mechanical Jam	15	15
Mechanical Problem	15	15
Component Missing	14	14
Product Quality Problem	13	13
Defective Device	13	13
Physical Resistance/Sticking	12	12
Positioning Problem	10	10
Fail-Safe Problem	9	9
Device Appears to Trigger Rejection	9	9
Component or Accessory Incompatibility	9	9
Patient Device Interaction Problem	8	8
Therapeutic or Diagnostic Output Failure	8	8
Difficult to Insert	5	5
Misassembly by Users	5	5
Packaging Problem	4	4
No Device Output	4	4
Material Separation	3	3
No Apparent Adverse Event	3	3
Failure to Cycle	3	3
Device Difficult to Setup or Prepare	2	2
Use of Device Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Unexpected Shutdown	2	2
Improper or Incorrect Procedure or Method	2	2
Activation, Positioning or Separation Problem	2	2
Leak/Splash	2	2
Unraveled Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1126	1127
Failure to Anastomose	541	541
Tissue Breakdown	484	484
Insufficient Information	207	207
Hemorrhage/Bleeding	100	100
Laceration(s)	71	71
Unspecified Tissue Injury	48	48
Wound Dehiscence	34	36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	29	29
Pain	26	28
Adhesion(s)	25	25
Inflammation	22	22
Ascites	21	21
Unintended Radiation Exposure	19	19
Unspecified Infection	19	21
Abscess	19	21
Sepsis	18	18
Fluid Discharge	16	16
Hematoma	16	16
Fistula	14	14
Abdominal Pain	13	13
Distress	12	12
Emotional Changes	12	12
Fever	10	10
Peritonitis	10	10
Electrolyte Imbalance	10	10
Abdominal Distention	10	10
Swelling/ Edema	10	10
Muscle Weakness	10	10
Impaired Healing	10	10
Anemia	9	9
No Known Impact Or Consequence To Patient	9	9
Foreign Body In Patient	9	9
Hernia	9	9
Anxiety	8	8
Shock	8	8
Deformity/ Disfigurement	8	8
Nausea	8	8
Septic Shock	8	8
Purulent Discharge	7	7
Renal Failure	7	7
Bowel Perforation	7	7
Post Operative Wound Infection	7	7
Discomfort	7	7
Organ Dehiscence	6	6
Perforation	6	6
Skin Inflammation/ Irritation	6	6
Rectal Anastomotic Leakage	6	6
Obstruction/Occlusion	6	6
Tachycardia	6	6