TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
KARL STORZ SE & CO.KG
	SUBSTANTIALLY EQUIVALENT	2
1. K243409 KARL STORZ Pediatric Cysto-Urethro-Fiberscope (112 ...
2. K244001 KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KA ...

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	31	31
Contamination /Decontamination Problem	19	19
Detachment of Device or Device Component	14	14
Material Separation	12	12
Fracture	9	9
Microbial Contamination of Device	8	8
Mechanical Problem	7	7
Insufficient Information	7	7
Material Integrity Problem	7	7
Material Fragmentation	6	6
Leak/Splash	4	4
Chemical Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Device Reprocessing Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Peeled/Delaminated	3	3
Failure to Clean Adequately	2	2
Use of Device Problem	2	2
Component Missing	2	2
Material Deformation	2	2
Optical Problem	2	2
No Apparent Adverse Event	2	2
Failure to Conduct	2	2
Calcified	2	2
Optical Obstruction	2	2
Smoking	1	1
Contamination	1	1
Difficult to Remove	1	1
Material Puncture/Hole	1	1
Material Invagination	1	1
Material Discolored	1	1
Failure to Power Up	1	1
Gas/Air Leak	1	1
Device Difficult to Maintain	1	1
Material Perforation	1	1
Blocked Connection	1	1
Device Damaged by Another Device	1	1
Crack	1	1
Device Handling Problem	1	1
Physical Resistance/Sticking	1	1
No Display/Image	1	1
Separation Problem	1	1
Device-Device Incompatibility	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Sparking	1	1
Corroded	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Misfocusing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	60	60
Insufficient Information	33	33
Unspecified Infection	16	16
Bacterial Infection	13	13
Foreign Body In Patient	10	10
No Consequences Or Impact To Patient	7	7
Urinary Tract Infection	6	6
Unspecified Kidney or Urinary Problem	4	4
Device Embedded In Tissue or Plaque	4	4
Patient Problem/Medical Problem	3	3
Hemorrhage/Bleeding	3	3
Skin Inflammation/ Irritation	2	2
Post Operative Wound Infection	2	2
No Known Impact Or Consequence To Patient	2	2
No Patient Involvement	2	2
Unintended Radiation Exposure	2	2
Intra-Abdominal Hemorrhage	1	1
Bowel Perforation	1	1
Burn(s)	1	1
Fever	1	1
Urinary Retention	1	1
Pain	1	1
Unspecified Hepatic or Biliary Problem	1	1
Pneumonia	1	1
Tissue Damage	1	1
Unspecified Heart Problem	1	1
Bruise/Contusion	1	1