TPLC - Total Product Life Cycle

• Device: arthroscope
• Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
• Product Code: HRX
• Regulation Number: 888.1100
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
A.M. SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED MEDICAL SYSTEMS GROUP SRL
	SUBSTANTIALLY EQUIVALENT	1
AJU PHARM CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
ALTOMEC ENDOSCOPY INC
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	1
ASAP ENDOSCOPIC PRODUCTS GMBH
	SUBSTANTIALLY EQUIVALENT	1
AXIS SURGICAL TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	1
BAYLIS MEDICAL CO., INC.
	SUBSTANTIALLY EQUIVALENT	1
BAYLIS MEDICAL COMPANY INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOPSYBELL S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
BIOVISION TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
BLAZEJEWSKI MEDI-TECH GMBH
	SUBSTANTIALLY EQUIVALENT	1
CAREFUSION
	SUBSTANTIALLY EQUIVALENT	4
CIT ORTHO
	SUBSTANTIALLY EQUIVALENT	1
CLARUS MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CONMED LINVATEC
	SUBSTANTIALLY EQUIVALENT	1
CORESPINE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
	SUBSTANTIALLY EQUIVALENT	3
DEPUY MITEK, INC.
	SUBSTANTIALLY EQUIVALENT	1
E SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
EBERLE GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
EFS EBERLE FEINWERKTECHNISCHE SYSTEME
	SUBSTANTIALLY EQUIVALENT	1
ELLIQUENCE, LLC
	SUBSTANTIALLY EQUIVALENT	1
GALLINI MEDICAL DEVICES, SRL
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
HAND BIOMECHANICS LAB, INC
	SUBSTANTIALLY EQUIVALENT	1
HEMODIA S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
HEMODIA SAS
	SUBSTANTIALLY EQUIVALENT	3
HOOGLAND SPINE PRODUCTS GMBH
	SUBSTANTIALLY EQUIVALENT	2
HYDROCISION, INC.
	SUBSTANTIALLY EQUIVALENT	2
IMEDICOM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
INTEGRATED ENDOSCOPY, INC.
	SUBSTANTIALLY EQUIVALENT	2
INTRAVU, INC.
	SUBSTANTIALLY EQUIVALENT	1
IZI MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU CHANGMEI MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY-AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
LAURIMED LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL VISION AB
	SUBSTANTIALLY EQUIVALENT	1
MEDISISS
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	2
MEDOS INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MICROAIRE SURGICAL INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	2
MICROAIRE SURGICAL INSTRUMENTS LLC
	SUBSTANTIALLY EQUIVALENT	1
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MYELOTEC
	SUBSTANTIALLY EQUIVALENT	1
NLT SPINE LTD
	SUBSTANTIALLY EQUIVALENT	3
OK MEDINET KOREA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS WINTER & IBE GMBH
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIC SCIENCES, INC
	SUBSTANTIALLY EQUIVALENT	2
OUROBOROS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PRISTINE SURGICAL
	SUBSTANTIALLY EQUIVALENT	2
PROSURG, INC
	SUBSTANTIALLY EQUIVALENT	1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	3
RENOVO, INC.
	SUBSTANTIALLY EQUIVALENT	1
RZ MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
SCHOLLY FIBEROPTIC GMBH
	SUBSTANTIALLY EQUIVALENT	1
SKELETAL DYNAMICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINAL DEVICES, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINE VIEW, INC.
	SUBSTANTIALLY EQUIVALENT	6
STRYKER
	SUBSTANTIALLY EQUIVALENT	2
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
STRYKER ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	2
TAEYEON MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THEKEN SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
TRANSCORP, INC.
	SUBSTANTIALLY EQUIVALENT	1
TRICE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TRICE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
VERTIFLEX, INC.
	SUBSTANTIALLY EQUIVALENT	1
VERTOS MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
VISEON, INC.
	SUBSTANTIALLY EQUIVALENT	2
VISIONSCOPE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
VISIONSENSE LTD
	SUBSTANTIALLY EQUIVALENT	1
VISIONSENSE LTD.
	SUBSTANTIALLY EQUIVALENT	1
W.O.M. WORLD OF MEDICINE GMBH
	SUBSTANTIALLY EQUIVALENT	1
WEMED BIO-TECH INC.
	SUBSTANTIALLY EQUIVALENT	1
X-STEN CORP.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	800	800
2015	763	763
2016	469	524
2017	934	1063
2018	1581	1682
2019	1676	1676
2020	1706	1706
2021	1908	1908
2022	1407	1407
2023	1853	1853
2024	1610	1610

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1758	1759
Display or Visual Feedback Problem	709	709
Material Rupture	690	690
Increase in Pressure	672	672
Use of Device Problem	669	669
Electrical Shorting	640	640
Overheating of Device	634	685
Detachment of Device or Device Component	548	554
Poor Quality Image	532	532
Electrical /Electronic Property Problem	439	439
Optical Problem	416	416
Leak/Splash	376	409
Pressure Problem	372	372
Overfill	365	365
Device-Device Incompatibility	331	331
Improper Flow or Infusion	322	322
Crack	312	312
Infusion or Flow Problem	307	307
Adverse Event Without Identified Device or Use Problem	291	291
Appropriate Term/Code Not Available	265	265
Suction Failure	246	246
Output Problem	243	243
No Display/Image	234	234
Device Operates Differently Than Expected	234	236
Mechanical Jam	224	233
Mechanical Problem	224	224
Scratched Material	217	217
Material Disintegration	183	192
Defective Device	180	180
Excess Flow or Over-Infusion	175	175
Device Remains Activated	174	180
Physical Resistance/Sticking	158	162
Fluid/Blood Leak	154	159
Metal Shedding Debris	138	201
Insufficient Information	133	133
Material Fragmentation	130	134
Noise, Audible	115	115
Intermittent Loss of Power	111	111
Disassembly	110	149
Corroded	109	109
Material Deformation	104	104
Component Missing	102	102
Suction Problem	96	96
Fracture	95	95
Intermittent Continuity	88	88
Smoking	86	87
Material Frayed	85	85
Device Contaminated During Manufacture or Shipping	84	84
Unknown (for use when the device problem is not known)	84	84
Detachment Of Device Component	78	78

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6646	6646
No Consequences Or Impact To Patient	2880	2963
No Known Impact Or Consequence To Patient	2332	2409
No Patient Involvement	1103	1240
Insufficient Information	275	275
Not Applicable	268	268
No Information	241	241
Extravasation	230	230
Foreign Body In Patient	207	207
No Code Available	137	137
Swelling	122	123
Swelling/ Edema	116	116
Device Embedded In Tissue or Plaque	109	109
Pain	79	79
Unspecified Infection	47	47
Bone Fracture(s)	44	44
Burn(s)	39	39
Injury	28	28
Unknown (for use when the patient's condition is not known)	27	27
Unspecified Tissue Injury	25	25
Tissue Damage	24	24
Edema	23	23
Joint Swelling	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Hematoma	19	19
Surgical procedure, delayed	14	14
Hemorrhage/Bleeding	12	12
Numbness	11	11
Pulmonary Embolism	9	9
Inflammation	9	9
Laceration(s)	9	9
Nerve Damage	8	8
Loss of Range of Motion	8	8
Abdominal Distention	8	8
Cerebrospinal Fluid Leakage	7	7
Paralysis	6	6
Post Operative Wound Infection	6	6
Death	6	6
Discomfort	5	5
Inadequate Pain Relief	5	5
Overdose	5	5
Neurological Deficit/Dysfunction	5	5
Burn, Thermal	5	5
Rupture	5	5
Burning Sensation	4	4
Fever	4	4
Dyspnea	4	4
Shock	4	4
Patient Problem/Medical Problem	4	4
Muscle Weakness	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	ADRIA SRL	II	Oct-19-2021
2	Ascent Healthcare Solutions	II	Feb-03-2012
3	Biomet, Inc.	II	May-26-2016
4	Biomet, Inc.	II	Mar-07-2011
5	Customed, Inc	II	Sep-03-2015
6	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	Jan-15-2016
7	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	Nov-08-2013
8	Instratek, Incorporated	II	Dec-22-2015
9	Linvatec Corp. dba ConMed Linvatec	II	Jul-10-2013
10	Linvatec Corp. dba ConMed Linvatec	II	Aug-24-2010
11	Linvatec Corp. dba ConMed Linvatec	II	Aug-09-2010
12	Linvatec Corp. dba ConMed Linvatec	I	Oct-01-2009
13	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
14	Medical Vision Ab	II	Aug-30-2016
15	Medtronic Sofamor Danek USA Inc	II	Jun-16-2020
16	Medtronic Spine LLC (formerly Kyphon Inc.)	II	Sep-09-2011
17	Medtronic Spine LLC, formerly Kyphon Inc	II	May-11-2009
18	MicroAire Surgical Instruments, LLC	II	Aug-08-2019
19	MicroAire Surgical Instruments, LLC	II	May-25-2018
20	Myelotec, Inc.	II	Jul-28-2017
21	ReNovo, Inc.	II	Mar-02-2021
22	Richard Wolf GmbH	II	Aug-22-2018
23	Richard Wolf Medical Instruments Corp.	II	Feb-09-2016
24	Smith & Nephew, Inc.	II	Jul-24-2020
25	Smith & Nephew, Inc. Endoscopy Division	II	Sep-21-2009
26	Stryker Endoscopy	II	Jun-25-2014
27	Stryker Endoscopy	II	Apr-08-2011
28	Stryker Endoscopy	II	Dec-28-2010
29	Stryker Endoscopy	II	Jan-21-2009
30	Stryker Endoscopy	II	Jan-16-2009
31	Stryker GmbH	II	Aug-28-2019
32	Stryker GmbH	II	Jun-20-2019
33	Stryker Instruments Div. of Stryker Corporation	II	Mar-28-2018
34	Stryker Instruments Div. of Stryker Corporation	II	Nov-01-2013
35	Stryker Instruments Division of Stryker Corporation	II	Mar-28-2011
36	Stryker Sustainability Solutions	II	Mar-05-2019
37	Surgical Instrument Service And Savings, Inc.	II	Jul-01-2013
38	The Anspach Effort, Inc.	II	Jun-25-2014
39	WOM World Of Medicine AG	II	Jul-01-2024
40	Zimmer, Inc.	II	Apr-01-2013