PENTAX
Received May 3, 2022 · Event occurred Apr 15, 2022
Report 9610877-2022-00498 · MDR key 14266528
Device
Generic name
Hot Hemostasis Forceps
Manufacturer
Hoya Corporation Pentax Tokyo OfficeModel number
HDB2418WProduct problems
- Unintended Movement
- Unintended Movement
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: H4:DEVICE MANUFACTURE DATE. EVALUATION SUMMARY: WE INVESTIGATED THE DEFECTIVE DEVICE. AS A RESULT OF THE INVESTIGATION, THE REPORTED DEFECT WAS NOT REPRODUCED. IT WAS CONFIRMED THAT IT WAS A NORMAL PRODUCT. WE ALSO CHECKED THE DHR AND CONFIRMED THAT THERE WAS NO PROBLEM.
Additional Manufacturer Narrative
THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.
Description of Event or Problem
DIFFICULT TO OPEN AND CLOSE THE CUP WHEN I CHECKED THE OPENING AND CLOSING OF FORCEPS BEFORE INSERTING THE ENDOSCOPE, IT DID NOT OPEN. THERE WAS NO REPORT OF PATIENT HARM. THE TIME OF EVENT IS BEFORE USE.