Arch Koh-Efficient KCS-ARCH-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937015218), received between May 4, 2021 and May 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2021Break

  PER REPORT- EVENT INFORMATION: TRANSLATION IN ENGLISH : "THE CUP IS BROKEN IN THREE PARTS". FOLLOW-UP INITIATED FOR ADDITIONAL INFORMATION. 04/12/2021- UPDATE: FOLLOW-UP RESPONSE STATED- NO INVOLVEMENT FOR THE PATIENT. WAS THERE ANY ADVERSE EFFECT AS A RESULT OF REPORTED CONDITION? PATIENT INJURY? NO CONDITION REPORTED FOR THE PATIENT. NO ADDITIONAL MEDICAL ATTENTION. WAS REPORTED CONDITION DURING PROCEDURE? NO. WHAT PROCEDURE WAS THE PHYSICIAN PERFORMING? ROBOTIC HYSTERECTOMY. DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE/HOW DID PHYSICIAN COMPLETE THE PROCEDURE/ WAS THERE ANY FRAGMENT LEFT IN THE PATIENT? THE PROBLEM OCCURRED AT THE END OF SURGERY, NO PROBLEM DURING. WAS THERE ANY SIGNIFICANT DELAY AS RESULT OF THE REPORTED CONDITION? NO DELAY. KOH-EFF ARCH 4-0CM HARMNC, KCS-ARCH-40. E-COMPLAINT- (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768720 ↗