FDA Adverse Event
Malfunction
Summary report: N
PENTAX
MDR report key: 12611709
·
Received October 11, 2021
Report
- Report Number
- 9610877-2021-01155
- Event Type
- Malfunction
- Date Received
- October 11, 2021
- Date of Event
- September 23, 2021
- Report Date
- February 16, 2022
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- ODG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
EVALUATION SUMMARY: THE SCOPE REPAIRED.
Additional Manufacturer Narrative · 0
IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG36-J10UR-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K200090.
Description of Event or Problem · 0
SINGE USE BRUSH STUCK INSIDE THE OP-CHANNEL. THIS EVENT OCCURRED AT THE TIME OF REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1509667 | PENTAX | DIGITAL RADIAL ULTRASOUND SCOPE | ODG | HOYA CORPORATION PENTAX TOKYO OFFICE | EG36-J10UR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |