TPLC - Total Product Life Cycle

show TPLC since

Device	stapler, surgical
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	269	269
Failure to Form Staple	218	218
Adverse Event Without Identified Device or Use Problem	142	142
Detachment of Device or Device Component	112	112
Misfire	103	103
Break	65	65
Difficult to Remove	59	59
Mechanics Altered	58	58
Failure to Align	35	35
Loss of or Failure to Bond	29	29
Firing Problem	25	25
Human-Device Interface Problem	24	24
Failure to Cut	19	19
Mechanical Problem	18	18
Material Twisted/Bent	18	18
Expulsion	17	17
Insufficient Information	17	17
Entrapment of Device	16	16
Mechanical Jam	16	16
Difficult to Open or Close	16	16
Noise, Audible	14	14
Device Slipped	12	12
Retraction Problem	11	11
Physical Resistance/Sticking	9	9
Protective Measures Problem	9	9
Product Quality Problem	9	9
Therapeutic or Diagnostic Output Failure	8	8
Defective Device	7	7
Patient Device Interaction Problem	7	7
Fail-Safe Problem	7	7
Device Appears to Trigger Rejection	5	5
Component or Accessory Incompatibility	4	4
Activation, Positioning or Separation Problem	4	4
Incomplete or Inadequate Connection	4	4
Appropriate Term/Code Not Available	4	4
Component Missing	4	4
Misassembly by Users	4	4
No Device Output	3	3
Use of Device Problem	3	3
Output Problem	3	3
Leak/Splash	3	3
Material Separation	2	2
Tear, Rip or Hole in Device Packaging	2	2
Device Dislodged or Dislocated	2	2
Nonstandard Device	2	2
Patient-Device Incompatibility	2	2
Activation Problem	2	2
Loose or Intermittent Connection	2	2
Improper or Incorrect Procedure or Method	2	2
Structural Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	536	536
Failure to Anastomose	231	231
Tissue Breakdown	229	229
Insufficient Information	112	112
Hemorrhage/Bleeding	50	50
Wound Dehiscence	34	34
Unspecified Tissue Injury	34	34
No Known Impact Or Consequence To Patient	33	33
Laceration(s)	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Abscess	14	14
Unspecified Infection	13	13
Pain	13	13
Inflammation	13	13
Adhesion(s)	12	12
Ascites	11	11
No Consequences Or Impact To Patient	10	10
Fistula	9	9
Hematoma	9	9
Sepsis	9	9
Fever	8	8
Fluid Discharge	8	8
Nausea	8	8
Impaired Healing	8	8
No Code Available	7	7
No Information	6	6
Abdominal Distention	6	6
Hernia	6	6
Purulent Discharge	6	6
Post Operative Wound Infection	6	6
Rectal Anastomotic Leakage	5	5
Stenosis	5	5
Perforation	5	5
Vomiting	5	5
Obstruction/Occlusion	5	5
Unintended Radiation Exposure	5	5
Bowel Perforation	4	4
Emotional Changes	4	4
Blood Loss	4	4
Death	4	4
Peritonitis	4	4
Electrolyte Imbalance	4	4
Swelling/ Edema	3	3
Tissue Damage	3	3
Scar Tissue	3	3
Low Blood Pressure/ Hypotension	3	3
Distress	3	3
Foreign Body In Patient	3	3
Abdominal Pain	3	3
Hypersensitivity/Allergic reaction	3	3