TPLC - Total Product Life Cycle

• Device: kit, nephroscope
• Regulation Description: Endoscope and accessories.
• Product Code: FGA
• Regulation Number: 876.1500
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
KARL STORZ SE & CO. KG
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2022	1	1
2023	11	11
2024	23	25
2025	37	37
2026	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	33	33
Adverse Event Without Identified Device or Use Problem	8	10
Detachment of Device or Device Component	6	6
Crack	5	5
Poor Quality Image	4	4
Material Fragmentation	3	3
Optical Problem	3	3
Material Twisted/Bent	3	3
Insufficient Information	2	2
Output Problem	2	2
Material Integrity Problem	2	2
Component Missing	2	2
Chemical Problem	1	1
Material Separation	1	1
Inadequate or Insufficient Training	1	1
Unstable	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Component	1	1
Image Display Error/Artifact	1	1
Leak/Splash	1	1
Mechanical Problem	1	1
Melted	1	1
Erratic or Intermittent Display	1	1
No Display/Image	1	1
Fracture	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	55	55
Insufficient Information	14	16
Hemorrhage/Bleeding	7	9
Septic Shock	6	8
Necrosis	4	6
Vascular Dissection	4	6
Increased Intra-Peritoneal Volume (IIPV)	4	6
Ischemia	4	6
Rupture	4	6
Cardiac Arrest	4	6
Thrombosis/Thrombus	4	6
Disseminated Intravascular Coagulation (DIC)	4	6
Unspecified Kidney or Urinary Problem	4	6
Aneurysm	4	6
Hypoxia	4	6
Ascites	4	6
Respiratory Failure	4	6
Sepsis	2	2
Foreign Body In Patient	2	2
Low Blood Pressure/ Hypotension	2	2
Ventilator Dependent	2	2
Anemia	1	1
Convulsion/Seizure	1	1
Urinary Tract Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Karl Storz Endoscopy	II	Sep-24-2024