TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	5	5
2020	1	1
2021	5	5
2022	4	4
2023	2	2
2024	239	239

Device Problems	MDRs with this Device Problem	Events in those MDRs
Poor Quality Image	97	97
No Display/Image	45	45
Communication or Transmission Problem	23	23
Break	20	20
Scratched Material	14	14
Display or Visual Feedback Problem	9	9
Material Discolored	8	8
Erratic or Intermittent Display	7	7
Material Integrity Problem	7	7
Failure to Clean Adequately	7	7
Contamination	6	6
Optical Problem	5	5
Dent in Material	5	5
Image Orientation Incorrect	4	4
Image Display Error/Artifact	4	4
Crack	4	4
Output Problem	4	4
Loose or Intermittent Connection	4	4
Material Split, Cut or Torn	3	3
Unintended Movement	2	2
Leak/Splash	2	2
Detachment of Device or Device Component	2	2
Material Opacification	1	1
Display Difficult to Read	1	1
Material Puncture/Hole	1	1
Mechanical Problem	1	1
Smoking	1	1
Defective Device	1	1
Defective Component	1	1
Moisture Damage	1	1
Optical Distortion	1	1
Contamination /Decontamination Problem	1	1
Disconnection	1	1
Material Fragmentation	1	1
Gas/Air Leak	1	1
Misfocusing	1	1
Material Deformation	1	1
Corroded	1	1
Connection Problem	1	1
Optical Discoloration	1	1
Flushing Problem	1	1
Optical Obstruction	1	1
Self-Activation or Keying	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	247	247
No Known Impact Or Consequence To Patient	6	6
Insufficient Information	3	3
Foreign Body In Patient	1	1