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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device staple, implantable
Product CodeGDW
Regulation Number 878.4750
Device Class 2


Premarket Reviews
ManufacturerDecision
ANIKA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 14
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DAVOL INC., SUBSIDIARY OF C.R. BARD
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY LLC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 3
EZISURG (SUZHOU) MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EZISURG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
FENGH MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LEXINGTON MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NINGBO VERYKIND MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
REACH SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 1
SURGIMATIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIA SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
WUXI BEIEN SURGERY DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 16597 16597
2020 12327 12327
2021 13015 13015
2022 13607 13607
2023 14684 14684
2024 1379 1379

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 25549 25549
Failure to Form Staple 11494 11494
Misfire 7518 7518
Adverse Event Without Identified Device or Use Problem 7265 7265
Difficult to Open or Close 6671 6671
Break 3650 3650
Entrapment of Device 2840 2840
Detachment of Device or Device Component 2839 2839
Human-Device Interface Problem 2211 2211
Insufficient Information 2211 2211
Noise, Audible 1657 1657
Failure to Cut 1399 1399
Complete Loss of Power 1392 1392
Mechanical Jam 1359 1359
Failure to Charge 1223 1223
Device Displays Incorrect Message 1042 1042
Mechanics Altered 1036 1036
Loss of or Failure to Bond 1028 1028
Firing Problem 985 985
Component or Accessory Incompatibility 894 894
No Apparent Adverse Event 892 892
Ejection Problem 710 710
Difficult to Remove 706 706
Material Integrity Problem 684 684
Retraction Problem 630 630
Patient Device Interaction Problem 592 592
Power Problem 519 519
Mechanical Problem 487 487
Expulsion 481 481
Activation Failure 480 480
Material Twisted/Bent 396 396
Physical Resistance/Sticking 354 354
Activation Problem 350 350
Corroded 324 324
Difficult or Delayed Positioning 294 294
Device Difficult to Setup or Prepare 284 284
Failure to Align 262 262
Device Markings/Labelling Problem 255 255
Fluid/Blood Leak 226 226
Device Slipped 225 225
Positioning Failure 220 220
Unintended Movement 219 219
Failure to Power Up 217 217
Unintended Ejection 207 207
Delivered as Unsterile Product 195 195
Appropriate Term/Code Not Available 183 183
Positioning Problem 169 169
Product Quality Problem 160 160
Activation, Positioning or Separation Problem 158 158
Gas/Air Leak 155 155
Difficult to Insert 150 150
Tear, Rip or Hole in Device Packaging 148 148
Device Misassembled During Manufacturing /Shipping 146 146
Self-Activation or Keying 146 146
Nonstandard Device 146 146
Defective Device 141 141
Failure to Read Input Signal 123 123
Unintended System Motion 119 119
Leak/Splash 111 111
Failure to Eject 105 105
Component Missing 98 98
Material Separation 97 97
Separation Problem 95 95
No Display/Image 94 94
Computer Software Problem 90 90
Manufacturing, Packaging or Shipping Problem 89 89
Electrical /Electronic Property Problem 81 81
Material Protrusion/Extrusion 76 76
Difficult or Delayed Activation 72 72
Therapeutic or Diagnostic Output Failure 71 71
Failure to Cycle 70 70
Overheating of Device 70 70
Separation Failure 64 64
Premature End-of-Life Indicator 63 63
No Device Output 62 62
Failure to Advance 62 62
Structural Problem 62 62
Use of Device Problem 62 62
Incorrect, Inadequate or Imprecise Result or Readings 61 61
Material Fragmentation 58 58
Battery Problem 57 57
Fail-Safe Problem 53 53
Protective Measures Problem 52 52
Excessive Heating 52 52
Device Fell 52 52
Material Deformation 51 51
Unraveled Material 49 49
Device Contamination with Chemical or Other Material 44 44
Premature Activation 44 44
Loose or Intermittent Connection 44 44
Output Problem 43 43
Patient-Device Incompatibility 40 40
Defective Component 37 37
Application Program Version or Upgrade Problem 36 36
Display or Visual Feedback Problem 36 36
Material Split, Cut or Torn 36 36
Calibration Problem 34 34
Packaging Problem 33 33
Difficult to Advance 32 32
Device Remains Activated 32 32

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33228 33228
No Consequences Or Impact To Patient 18059 18059
No Code Available 4579 4580
Unspecified Tissue Injury 4403 4403
Insufficient Information 4228 4228
Failure to Anastomose 3352 3352
Hemorrhage/Bleeding 2688 2688
No Known Impact Or Consequence To Patient 2249 2249
Tissue Damage 1343 1343
No Information 1176 1176
Blood Loss 963 964
No Patient Involvement 921 921
Tissue Breakdown 729 729
Pain 493 493
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 491 491
Fistula 430 430
Unspecified Infection 334 334
Abscess 305 305
Hematoma 267 267
Foreign Body In Patient 266 266
Sepsis 244 244
Abdominal Pain 243 243
Fever 229 229
Obstruction/Occlusion 215 215
Laceration(s) 208 208
Injury 171 171
Unintended Radiation Exposure 166 166
Death 160 161
Hernia 150 150
Peritonitis 148 148
Inflammation 140 140
Vomiting 111 111
Wound Dehiscence 110 110
Seroma 108 108
Post Operative Wound Infection 103 103
Radiation Exposure, Unintended 99 99
Not Applicable 98 98
Pneumothorax 94 94
Tachycardia 94 94
Nausea 90 90
Pleural Effusion 82 82
Septic Shock 79 79
Pneumonia 73 73
Adhesion(s) 73 73
Low Blood Pressure/ Hypotension 71 71
Bowel Perforation 71 71
Device Embedded In Tissue or Plaque 67 67
Necrosis 67 67
Stenosis 64 64
Anemia 62 62
Diarrhea 55 55
Perforation 55 55
Pulmonary Emphysema 54 54
Impaired Healing 54 54
Incontinence 53 53
Urinary Tract Infection 51 51
Fluid Discharge 51 51
Abdominal Distention 48 48
Ulcer 43 43
High Blood Pressure/ Hypertension 43 43
Ischemia 41 41
Thrombosis/Thrombus 41 41
Cardiac Arrest 40 40
Urinary Retention 39 39
Bacterial Infection 38 38
Dyspnea 36 36
Renal Failure 36 36
Thrombosis 35 35
Swelling/ Edema 35 35
Purulent Discharge 33 33
Pulmonary Embolism 33 33
Discomfort 32 32
Respiratory Failure 31 31
Perforation of Vessels 30 30
Exsanguination 29 29
Distress 29 29
Unspecified Respiratory Problem 29 29
Ascites 29 29
Rectal Anastomotic Leakage 27 27
Dehydration 23 23
Failure of Implant 23 23
Myocardial Infarction 21 21
Shock 21 21
Organ Dehiscence 21 21
Emotional Changes 19 19
Swelling 18 18
Scar Tissue 16 16
Hypoxia 16 16
Itching Sensation 15 15
Muscle Weakness 15 15
Dysphagia/ Odynophagia 15 15
Chest Pain 15 15
Fibrosis 15 15
Anxiety 14 14
Hypersensitivity/Allergic reaction 14 14
Ecchymosis 13 13
Chills 13 13
Cancer 13 13
Weight Changes 13 13
Syncope/Fainting 13 13

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN LLC II Feb-18-2020
2 Covidien LLC II Jun-16-2019
3 Covidien Llc II Apr-13-2021
4 Covidien Llc II Dec-29-2020
5 Covidien, LP II Mar-06-2023
6 Covidien, LP II Apr-09-2021
7 Covidien, LP II Oct-01-2020
8 Ethicon Endo-Surgery Inc II Jan-26-2024
9 Ethicon Endo-Surgery Inc II Aug-19-2021
10 Ethicon Endo-Surgery Inc I Oct-29-2019
11 Ethicon Endo-Surgery Inc I May-15-2019
12 Ethicon Endo-Surgery Inc II Jan-08-2019
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