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MAUDE
MDR
9769311
MAUDE MDR 9769311
MDR report key
9769311
Report number
8010047-2020-01556
Event key
0
Event type
3
Date received
2020-02-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3
Related Records
#
Product code FGB
Manufacturer Contact
#
Contact
MR KAZUTAKA MATSUMOTO
Address
2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8 JA
Phone
426-426-4264
Report source
M
Manufacturer link flag
Y
Devices
#
Seq, Brand, Generic table
Seq
Brand
Generic
Manufacturer
Product code
Model
Catalog
Lot
PMA
510(k)
Implant
Evaluated
Availability
1
URETERO-RENO VIDEOSCOPE
URETERO-RENO VIDEOSCOPE
OLYMPUS MEDICAL SYSTEMS CORP.
FGB
URF-V2R
Y
R
Patients
#
Sequence, Received, Treatment table
Sequence
Received
Treatment
Outcome
1
2020-02-28
0
Event Narratives
#
No narrative records found.
Related GUDID Devices By Product Code
#
Primary DI, Brand, Company table
Primary DI
Brand
Company
Product code
Published
06972304750407
DeepEye
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
FGB
2026-05-22
06972304750414
DeepEye
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
FGB
2026-05-22
16972304750381
DeepEye
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
FGB
2026-05-22
16972304750398
DeepEye
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
FGB
2026-05-22
16972304750428
DeepEye
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
FGB
2026-05-22
16972304750435
DeepEye
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
FGB
2026-05-22
00810116023387
Dornier Axis II
DORNIER MEDTECH AMERICA, INC.
FGB
2026-05-06
00810116023400
Dornier MedTech
DORNIER MEDTECH AMERICA, INC.
FGB
2026-05-06
00810116023578
Dornier MedTech
DORNIER MEDTECH AMERICA, INC.
FGB
2026-05-06
10810068811046
MONARCH™Platform, Urology
Auris Health, Inc.
FGB
2026-05-05
10810068811053
Monarch® Ureteroscopy Kit
Auris Health, Inc.
FGB
2026-05-05
10810068811107
MONARCH™ Urology Irrigation Cartridge
Auris Health, Inc.
FGB
2026-05-04
10810068811121
MONARCH™ Ureteroscope Valve
Auris Health, Inc.
FGB
2026-05-04
00810116024056
Dornier MedTech
DORNIER MEDTECH AMERICA, INC.
FGB
2026-03-26
00810116024070
Dornier MedTech
DORNIER MEDTECH AMERICA, INC.
FGB
2026-03-26
00810116024094
Dornier MedTech
DORNIER MEDTECH AMERICA, INC.
FGB
2026-03-26
00810116024117
Dornier MedTech
DORNIER MEDTECH AMERICA, INC.
FGB
2026-03-26
06972520301216
Ascend™ Single-Use Flexible Ureteroscope
Guangzhou Red Pine Medical Instrument Co., Ltd.
FGB
2026-03-17
06972520301223
Ascend™ Single-Use Flexible Ureteroscope
Guangzhou Red Pine Medical Instrument Co., Ltd.
FGB
2026-03-17
06972520301230
Ascend™ Single-Use Flexible Ureteroscope
Guangzhou Red Pine Medical Instrument Co., Ltd.
FGB
2026-03-17
06972520301247
Ascend™ Single-Use Flexible Ureteroscope
Guangzhou Red Pine Medical Instrument Co., Ltd.
FGB
2026-03-17
06972520301254
Ascend™ Single-Use Flexible Ureteroscope
Guangzhou Red Pine Medical Instrument Co., Ltd.
FGB
2026-03-17
06972520301261
Ascend™ Single-Use Flexible Ureteroscope
Guangzhou Red Pine Medical Instrument Co., Ltd.
FGB
2026-03-17
06972520301278
Ascend™ Single-Use Flexible Ureteroscope
Guangzhou Red Pine Medical Instrument Co., Ltd.
FGB
2026-03-17
06972520301285
Ascend™ Single-Use Flexible Ureteroscope
Guangzhou Red Pine Medical Instrument Co., Ltd.
FGB
2026-03-17
00810116023370
Dornier MedTech
DORNIER MEDTECH AMERICA, INC.
FGB
2026-01-22
00810116023417
Dornier MedTech
DORNIER MEDTECH AMERICA, INC.
FGB
2026-01-22
00810116023523
Axis II
DORNIER MEDTECH AMERICA, INC.
FGB
2026-01-22
00810116023585
Dornier MedTech
DORNIER MEDTECH AMERICA, INC.
FGB
2026-01-22
06971176282924
Single Use Video Ureteroscope Direct In-Scope Suction
Zhuhai Pusen Medical Technology Co, Ltd
FGB
2026-01-13
Related PMN/PMA Records By Product Code
#
Type, Submission, Product code table
Type
Submission
Product code
Device
Applicant
Decision date
510(k)
K252929
FGB
Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)
Anhui Happiness Workshop Instruments Co., Ltd.
2026-04-09
510(k)
K260013
FGB
CVAC Image Processor
Calyxo, Inc.
2026-03-06
510(k)
K252468
FGB
Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)
Zhejiang Geyi Medical Instrument Co., Ltd.
2025-12-16
510(k)
K251951
FGB
Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)
Guangzhou Red Pine Medical Instrument Co., Ltd.
2025-12-16
510(k)
K253411
FGB
Miniature Telescope for Urology (27033AA)
Karl Storz SE & CO. KG
2025-11-18