TPLC - Total Product Life Cycle

• Device: endoscope, rigid
• Product Code: GCM
• Regulation Number: 876.1500
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH
	SUBSTANTIALLY EQUIVALENT	1
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	1	1
2015	1	1
2016	6	6
2017	3	3
2018	1	1
2019	5	5
2020	1	1
2021	5	5
2022	4	4
2023	2	2
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Clean Adequately	6	6
Poor Quality Image	5	5
Break	4	4
Material Fragmentation	2	2
Material Deformation	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Microbial Contamination of Device	2	2
Component Missing	1	1
Detachment of Device or Device Component	1	1
Optical Discoloration	1	1
Optical Distortion	1	1
Output Problem	1	1
Unintended Movement	1	1
Insufficient Information	1	1
Device Handling Problem	1	1
Mechanical Problem	1	1
Moisture Damage	1	1
Material Opacification	1	1
Smoking	1	1
Display or Visual Feedback Problem	1	1
Flushing Problem	1	1
Bent	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11	11
No Known Impact Or Consequence To Patient	8	8
Foreign Body In Patient	4	4
No Consequences Or Impact To Patient	2	2
No Patient Involvement	2	2
Insufficient Information	2	2
Device Embedded In Tissue or Plaque	1	1
Fungal Infection	1	1
Patient Problem/Medical Problem	1	1
Bacterial Infection	1	1
Cardiac Arrest	1	1
Death	1	1
Dehydration	1	1
Pain	1	1
Sepsis	1	1