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	741	779
Failure to Form Staple	651	670
Adverse Event Without Identified Device or Use Problem	464	490
Detachment of Device or Device Component	339	357
Misfire	288	296
Mechanics Altered	192	201
Difficult to Remove	177	188
Break	143	147
Difficult to Open or Close	101	101
Failure to Align	99	104
Human-Device Interface Problem	81	85
Incomplete or Inadequate Connection	69	69
Failure to Cut	66	69
Device Slipped	56	58
Insufficient Device Problem Information	48	51
Noise, Audible	45	45
Retraction Problem	44	44
Material Twisted/Bent	43	47
Firing Problem	35	35
Positioning Failure	34	34
Entrapment of Device	33	36
Loss of or Failure to Bond	29	37
Mechanical Jam	29	30
Expulsion	22	23
Protective Measures Problem	22	27
Ejection Problem	19	19
Component or Accessory Incompatibility	17	17
Component Missing	16	17
Material Integrity Problem	15	15
No Apparent Adverse Event	14	14
Fail-Safe Problem	13	15
Mechanical Problem	12	20
Patient Device Interaction Problem	11	11
Misassembly by Users	10	12
Positioning Problem	10	10
Device Difficult to Setup or Prepare	9	9
Difficult to Insert	8	8
Delivered as Unsterile Product	8	8
Packaging Problem	8	8
Product Quality Problem	7	7
Physical Resistance/Sticking	7	7
No Device Output	7	8
Activation Problem	5	5
Self-Activation or Keying	5	5
Material Separation	4	4
Device Appears to Trigger Rejection	4	4
Device Displays Incorrect Message	4	4
Separation Problem	4	4
Unintended Ejection	3	3
Material Fragmentation	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1762	1849
Failure to Anastomose	761	786
Tissue Breakdown	663	686
Insufficient Information	256	281
Hemorrhage/Blood Loss/Bleeding	150	159
Laceration(s)	96	99
Unspecified Tissue Injury	57	68
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	35	43
Pain	29	33
Unintended Radiation Exposure	26	28
Adhesion(s)	25	31
Inflammation	24	28
Fistula	24	27
Ascites	22	28
Abdominal Pain	21	21
Wound Dehiscence	20	31
Unspecified Infection	20	23
Sepsis	19	20
Abscess	19	23
Hematoma	18	23
Fluid Discharge	16	20
Septic Shock	13	14
Peritonitis	13	13
Emotional Changes	12	15
Distress	12	15
Abdominal Distention	11	14
Swelling/ Edema	10	12
Impaired Healing	10	13
Muscle Weakness/Atrophy	10	12
Anemia	10	11
Obstruction/Occlusion	10	11
Electrolyte Imbalance	10	14
Foreign Body In Patient	10	12
Nausea	9	11
Hernia	9	13
Fever	9	11
Deformity/ Disfigurement	8	8
Organ Dehiscence	8	8
Anxiety	8	9
Bowel Perforation	8	8
Shock	8	9
Tachycardia	7	7
Renal Failure	7	7
Purulent Discharge	7	10
Discomfort	7	9
Post Operative Wound Infection	7	7
Ulcer	6	7
Stenosis	6	8
Low Blood Pressure/ Hypotension	6	7
Depression	6	7

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