BRONCHOVIDEOSCOPE · BRONCHOVIDEOSCOPE
AIZU OLYMPUS CO., LTD. · Detachment of Device or Device Component
- Manufacturer contact t name
- Mr.
- Manufacturer contact state
- MA
- Manufacturer link flag
- Y
- Manufacturer g1 city
- AIZUWAKAMATSU-SHI, Fukushima
- Manufacturer contact address 1
- 800 West Park Drive
- Manufacturer contact pcity
- +1(508)2
- Event type
- Malfunction
- Report number
- 9610595-2026-70952
- Product problem flag
- Y
- Date received
- 20260831
- Date of event
- 20260715
- 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
- 965-8520
- Reporter country code
- UK
- Date added
- 20260831
- Manufacturer contact f name
- Todd
- Device date of manufacturer
- 20240725
- Previous use code
- U
- Manufacturer contact country
- US
- Date changed
- 20260831
- Health professional
- N
- Summary report flag
- N
- Manufacturer g1 zip code ext
- 520
- Date report
- 20260830
- Initial report to FDA
- No
- Manufacturer g1 country
- JA
- Manufacturer contact city
- Westborough
- MDR report key
- 50515036
- Date manufacturer received
- 20260804
- Report source code
- Manufacturer report
- Manufacturer g1 zip code
- 965-8
- Manufacturer g1 name
- AIZU OLYMPUS CO., LTD.
- Adverse event flag
- N
- Single use flag
- N
- Manufacturer g1 address 1
- 3-1-1 Niiderakita
- Manufacturer contact postal code
- 01581
- Type of report
- Initial submission
- Source type
- Company representation
- Device
- Device sequence number
- 16438
- Serviced by 3rd party flag
- N
- Date received
- 20260831
- Brand name
- BRONCHOVIDEOSCOPE
- Generic name
- BRONCHOVIDEOSCOPE
- Manufacturer d name
- AIZU OLYMPUS CO., LTD.
- Manufacturer d address 1
- 3-1-1 Niiderakita
- Manufacturer d city
- AIZUWAKAMATSU-SHI, Fukushima
- Manufacturer d zip code
- 965-8
- Manufacturer d zip code ext
- 520
- Manufacturer d country
- JA
- Manufacturer d postal code
- 965-8520
- Device operator
- OTHER
- Model number
- BF-1TH1200
- Device availability
- Yes
- Date returned to manufacturer
- 20260717
- Device report product code
- EOQ
- Device evaluated by manufacturer
- Y
- Combination product flag
- N
- Harmonized identifiers (openFDA)
- Device name
- Bronchoscope (Flexible Or Rigid)
- Medical specialty description
- Ear, Nose, Throat
- Regulation number
- 874.4680
- Device class
- 2
- Product problems
- Detachment of Device or Device Component
- Patient
- Patient sequence number
- 1
- Date received
- 20260831
- Patient sex
- Unknown
- Patient problems
- No Clinical Signs, Symptoms or Conditions
- MDR text
- MDR text key
- 16117502869
- Text type code
- Additional Manufacturer Narrative
- Patient sequence number
- 0
- Text
The device was returned to Olympus for inspection.Based on the results of the investigation and historical data, reasonably known information suggests probable causes such as damage or deterioration of parts due to wear and tear, without any design or manufacturing issue. The most probable cause of this complaint is expected or random component failure without any design or manufacturing issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
- MDR text key
- 15617502868
- Text type code
- Description of Event or Problem
- Patient sequence number
- 0
- Text
- It was observed that during the device evaluation, the bronchovideoscope had detached bending section cover adhesive. There was no patient involvement.