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	637	681
Failure to Form Staple	558	582
Adverse Event Without Identified Device or Use Problem	410	437
Detachment of Device or Device Component	299	317
Misfire	290	305
Mechanics Altered	176	186
Difficult to Remove	164	175
Break	134	142
Failure to Align	95	100
Human-Device Interface Problem	76	80
Incomplete or Inadequate Connection	66	66
Failure to Cut	56	59
Device Slipped	48	50
Retraction Problem	40	40
Material Twisted/Bent	40	45
Insufficient Information	38	41
Entrapment of Device	34	37
Firing Problem	30	30
Loss of or Failure to Bond	29	37
Difficult to Open or Close	27	28
Noise, Audible	25	25
Expulsion	22	23
Protective Measures Problem	20	25
Physical Resistance/Sticking	15	17
Mechanical Jam	15	24
Defective Device	15	17
Component Missing	14	15
Mechanical Problem	13	22
Product Quality Problem	13	13
Component or Accessory Incompatibility	12	12
Fail-Safe Problem	10	12
Positioning Problem	10	10
Device Appears to Trigger Rejection	9	9
Device Difficult to Setup or Prepare	9	9
Patient Device Interaction Problem	8	8
Packaging Problem	7	7
Misassembly by Users	7	9
No Device Output	7	8
Difficult to Insert	6	6
Positioning Failure	5	5
No Apparent Adverse Event	4	4
Therapeutic or Diagnostic Output Failure	4	6
Unexpected Shutdown	3	3
Failure to Cycle	3	3
Device Displays Incorrect Message	3	3
Use of Device Problem	3	4
Material Separation	3	3
Improper or Incorrect Procedure or Method	2	2
Tear, Rip or Hole in Device Packaging	2	2
Material Fragmentation	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1419	1506
Failure to Anastomose	702	727
Tissue Breakdown	591	614
Insufficient Information	233	258
Hemorrhage/Bleeding	123	132
Laceration(s)	88	91
Unspecified Tissue Injury	53	64
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	34	42
Pain	27	31
Unintended Radiation Exposure	25	27
Inflammation	24	28
Adhesion(s)	24	30
Ascites	22	28
Wound Dehiscence	20	31
Abdominal Pain	19	19
Unspecified Infection	19	22
Fistula	19	22
Sepsis	19	20
Abscess	18	22
Hematoma	17	22
Fluid Discharge	16	20
Septic Shock	13	14
Distress	12	15
Emotional Changes	12	15
Abdominal Distention	11	14
Peritonitis	11	11
Impaired Healing	10	13
Muscle Weakness	10	12
Foreign Body In Patient	10	12
Swelling/ Edema	10	12
Electrolyte Imbalance	10	14
Hernia	9	13
Fever	9	11
Anemia	9	10
Obstruction/Occlusion	9	10
Deformity/ Disfigurement	8	8
Anxiety	8	9
Nausea	8	10
Shock	8	9
Bowel Perforation	7	7
Discomfort	7	9
Organ Dehiscence	7	7
Purulent Discharge	7	10
Post Operative Wound Infection	7	7
Renal Failure	7	7
Depression	6	7
Vomiting	6	7
Pleural Effusion	6	7
Tachycardia	6	6
Stenosis	6	8

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien, LP	II	Jul-01-2022