4K CAMERA HEAD · AUTOCLAVABLE CAMERA HEAD
SHIRAKAWA OLYMPUS CO., LTD. · Gas/Air Leak
- Manufacturer g1 address 2
- Odakura, Nishigo-Mura,
- Manufacturer contact t name
- Mr.
- Manufacturer contact state
- MA
- Manufacturer link flag
- Y
- Manufacturer g1 city
- Nishishirakawa-Gun, Fukushima
- Manufacturer contact address 1
- 800 West Park Drive
- Manufacturer contact pcity
- +1(508)2
- Event type
- Malfunction
- Report number
- 3002808148-2026-30380
- Product problem flag
- Y
- Date received
- 20260831
- PMA pmn number
- K251336
- Date of event
- 20260611
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- 01581
- Reporter occupation code
- 003
- Manufacturer contact plocal
- +1(508)207-7661
- Noe summarized
- 1
- Manufacturer contact l name
- Brill
- Manufacturer g1 postal code
- 961-8061
- Reporter country code
- JA
- Date added
- 20260831
- Manufacturer contact f name
- Todd
- Previous use code
- U
- Manufacturer contact country
- US
- Date changed
- 20260831
- Health professional
- N
- Summary report flag
- N
- Manufacturer g1 zip code ext
- 061
- Date report
- 20260830
- Initial report to FDA
- No
- Manufacturer g1 country
- JA
- Manufacturer contact city
- Westborough
- MDR report key
- 50515038
- Date manufacturer received
- 20260824
- Report source code
- Manufacturer report
- Manufacturer g1 zip code
- 961-8
- Manufacturer g1 name
- SHIRAKAWA OLYMPUS CO., LTD.
- Adverse event flag
- N
- Single use flag
- N
- Manufacturer g1 address 1
- 3-1 Okamiyama
- Manufacturer contact postal code
- 01581
- Type of report
- Initial submission
- Source type
- Foreign, Company representation
- Device
- Device sequence number
- 15691
- Serviced by 3rd party flag
- N
- Date received
- 20260831
- Brand name
- 4K CAMERA HEAD
- Generic name
- AUTOCLAVABLE CAMERA HEAD
- Manufacturer d name
- SHIRAKAWA OLYMPUS CO., LTD.
- Manufacturer d address 1
- 3-1 Okamiyama
- Manufacturer d address 2
- Odakura, Nishigo-Mura,
- Manufacturer d city
- Nishishirakawa-Gun, Fukushima
- Manufacturer d zip code
- 961-8
- Manufacturer d zip code ext
- 061
- Manufacturer d country
- JA
- Manufacturer d postal code
- 961-8061
- Device operator
- OTHER
- Model number
- CH-S700-XZ-EA
- Device availability
- Yes
- Date returned to manufacturer
- 20260623
- Device report product code
- FET
- Device evaluated by manufacturer
- Y
- Combination product flag
- N
- Harmonized identifiers (openFDA)
- Device name
- Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1500
- Device class
- 2
- Product problems
- Gas/Air Leak
- Patient
- Patient sequence number
- 1
- Date received
- 20260831
- Patient sex
- Unknown
- Patient problems
- No Clinical Signs, Symptoms or Conditions