inforMED
MalfunctionGCL

PENTAX

Received Aug 11, 2021 · Event occurred Apr 21, 2021

Report 9610877-2021-10729 · MDR key 12305579

Device

Generic name

Forceps Toothedcup Reuse 2.4dia 150l

Product problems

  • Material Split, Cut or Torn
  • Material Split, Cut or Torn

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

DURING PENTAX INTERNAL REVIEW IT WAS DISCOVERED ON SEPTEMBER 6, 2021 THAT THE EVENT WAS NOT REPORTABLE BUT FILED UNDER MDR (9610877-2021-10729) WHICH WAS SUBMITTED ON AUGUST 11, 2021. THIS PRODUCT IS NOT REPORTABLE BECAUSE OF OEM PRODUCTS. PENTAX HAS FORWARDED THIS COMPLAINT TO THE LEGAL MANUFACTURER. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

Description of Event or Problem

DURING PENTAX INTERNAL REVIEW IT WAS DISCOVERED ON SEPTEMBER 6, 2021 THAT THE EVENT WAS NOT REPORTABLE BUT FILED UNDER MDR (9610877-2021-10729) WHICH WAS SUBMITTED ON AUGUST 11, 2021. THIS PRODUCT IS NOT REPORTABLE BECAUSE OF OEM PRODUCTS. PENTAX HAS FORWARDED THIS COMPLAINT TO THE LEGAL MANUFACTURER. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

Additional Manufacturer Narrative

THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL KA-2415S IS AVAILABLE IN THE USA WITH 510K NUMBER K951198. LOT NUMBER IS UNAVAILABLE. EVALUATION SUMMARY IT WAS CAUSED DUE TO AN EXCESSIVE FORCE APPLIED ON THE FORCE DURING USE. RELATED MDRS: 9610877-2021-10255 AND 9610877-2021-10730. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

Description of Event or Problem

THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. A THIRD INCIDENT WITH OUR FORCEPS. THEY BREAK SUDDENLY SO BIG PROBLEM TO REMOVE THEM. THEY NEVER SAW FORCEPS TO BREAK. 3 CASES, 3 DOCTORS AND 3 NURSES DIFFERENT. THE FIRST HAD NOT BEEN DECLARED. THE SECOND I MADE THE CLAIM. AND LAST WEEK A THIRD I AWAIT PHARMACIST STATEMENT. BESIDES, THEY REPORT TO ME THAT SINCE OUR FORCEPS THEY HAVE SENT 5 GASTROSCOPES TO REPAIR FOR PERFORMED SHEATH. CHANNEL OP 2.8MM. THEY ARE DIFFERENT DEVICES INVOLVED IN THE SAME DEFECT.