TPLC - Total Product Life Cycle

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Device	system, surgical, computer controlled instrument
Regulation Description	Endoscope and accessories.
Definition	If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product Code	NAY
Regulation Number	876.1500
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Split, Cut or Torn	27114	27114
Material Fragmentation	7307	7307
Detachment of Device or Device Component	5753	5755
Material Frayed	4971	4971
Break	4437	4440
Difficult to Open or Close	4434	4435
Visual Prompts will not Clear	4165	4167
Output Problem	2365	2365
Thermal Decomposition of Device	2163	2163
Unintended System Motion	2097	2097
Adverse Event Without Identified Device or Use Problem	1806	1807
Unintended Movement	1600	1600
No Apparent Adverse Event	1558	1558
No Device Output	1254	1254
Failure to Deliver Energy	1148	1148
Energy Output Problem	1112	1112
Arcing	893	893
Difficult to Remove	564	564
No Display/Image	480	480
Image Orientation Incorrect	459	459
Insufficient Information	445	445
Material Integrity Problem	434	434
Entrapment of Device	432	432
Physical Resistance/Sticking	376	376
Material Separation	364	364
Device Dislodged or Dislocated	321	321
Defective Device	308	310
Failure to Sense	256	256
Failure to Cut	252	258
Material Twisted/Bent	247	247
Appropriate Term/Code Not Available	211	211
Power Problem	185	185
Positioning Problem	178	178
Failure to Seal	172	172
Mechanical Problem	147	148
Defective Component	145	147
Grounding Malfunction	143	143
Device Displays Incorrect Message	134	136
Display or Visual Feedback Problem	129	130
Positioning Failure	116	116
Scratched Material	114	114
Fracture	96	96
Crack	94	94
Firing Problem	92	94
Poor Quality Image	89	89
Melted	86	86
Unexpected Shutdown	84	84
Failure to Fire	82	83
Smoking	80	80
Use of Device Problem	79	79

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	61807	61822
Insufficient Information	11208	11215
Foreign Body In Patient	1691	1692
Unspecified Tissue Injury	1222	1222
Hemorrhage/Bleeding	1193	1193
No Known Impact Or Consequence To Patient	1189	1192
Burn(s)	194	194
Device Embedded In Tissue or Plaque	183	183
Bowel Perforation	97	97
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	79	80
Perforation of Vessels	79	79
Hematoma	76	76
Unspecified Infection	70	71
Cardiac Arrest	70	70
Blood Loss	68	68
Failure to Anastomose	56	56
Sepsis	56	57
Injury	54	54
Pain	52	52
Fistula	48	49
Hernia	46	46
Great Vessel Perforation	44	44
Bacterial Infection	44	44
Laceration(s)	42	42
Obstruction/Occlusion	36	36
Pulmonary Embolism	36	36
Death	35	35
Pneumothorax	34	34
Abscess	30	30
Bowel Burn	30	30
Seroma	28	28
Thrombosis/Thrombus	26	26
Post Operative Wound Infection	25	25
Low Blood Pressure/ Hypotension	25	25
Pneumonia	24	24
Abdominal Pain	24	25
No Consequences Or Impact To Patient	23	23
Myocardial Infarction	23	23
Unspecified Vascular Problem	21	21
Rectal Anastomotic Leakage	21	21
Ischemia	20	20
Pleural Effusion	20	20
Perforation	19	19
Necrosis	19	19
Bruise/Contusion	17	17
Fever	17	17
Unspecified Gastrointestinal Problem	16	16
Nerve Damage	16	16
Urinary Tract Infection	15	15
Respiratory Tract Infection	15	15

Recalls
Manufacturer		Recall Class	Date Posted
1	Asensus Surgical Inc	I	Oct-30-2023
2	Intuitive Surgical Inc	II	May-05-2020
3	Intuitive Surgical, Inc.	II	Mar-12-2025
4	Intuitive Surgical, Inc.	II	Jan-16-2025
5	Intuitive Surgical, Inc.	II	Jan-10-2025
6	Intuitive Surgical, Inc.	II	Apr-11-2024
7	Intuitive Surgical, Inc.	II	Nov-28-2023
8	Intuitive Surgical, Inc.	II	Jun-30-2023
9	Intuitive Surgical, Inc.	II	Mar-28-2023
10	Intuitive Surgical, Inc.	II	Mar-16-2023
11	Intuitive Surgical, Inc.	II	Nov-30-2022
12	Intuitive Surgical, Inc.	II	Oct-25-2022
13	Intuitive Surgical, Inc.	II	Aug-01-2022
14	Intuitive Surgical, Inc.	II	Jul-25-2022
15	Intuitive Surgical, Inc.	II	May-31-2022
16	Intuitive Surgical, Inc.	II	Apr-22-2022
17	Intuitive Surgical, Inc.	II	Mar-01-2022
18	Intuitive Surgical, Inc.	II	Dec-27-2021
19	Intuitive Surgical, Inc.	II	Nov-23-2021
20	Intuitive Surgical, Inc.	II	Oct-23-2020
21	Intuitive Surgical, Inc.	II	Jun-03-2020
22	Intuitive Surgical, Inc.	II	Jun-01-2020
23	Intuitive Surgical, Inc.	II	May-11-2020
24	Intuitive Surgical, Inc.	II	May-06-2020
25	Intuitive Surgical, Inc.	II	Feb-06-2020
26	Intuitive Surgical, Inc.	II	Jan-31-2020
27	Intuitive Surgical, Inc.	II	Jan-24-2020
28	Olympus Corporation of the Americas	II	Jun-28-2024