SAFETOUCH 003984-901Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925000223), received between Feb 17, 2022 and Mar 7, 2023 — classified as 1 injury, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K171440); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  CUSTOMER SERVICE REPRESENTATIVE REPORTED A POTENTIAL OUT OF BOX FAILURE; DEVICE WAS REPORTED TO FAIL UPON INSTALLATION. ACCORDING TO THE REPORT, THE DEVICE 003984-901 BERKELEY SAFETOUCH COLLECTION SYSTEM WITH TISSUE TRAPS CASE WAS SHIPPED IN DECEMBER, AND THE EXPIRATION DATE IS NOVEMBER, MAKING THE COLLECTION SYSTEM UNUSABLE. THERE IS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16493517 ↗
• InjuryFeb 17, 2022Component Missing; Component Missing

  THE CUSTOMER REPORTS, DUE INSUFFICIENT SUPPLY OF CANISTER LIDS WITH THEIR STOCK OF SAFE TOUCH COLLECTION SYSTEMS, THE CUSTOMER "RIGGED" AN ALTERNATIVE SUCTION SET UP USING DIFFERENT CANISTER LIDS. THE CUSTOMER CONTACTED OLYMPUS TO GET ADDITIONAL CANISTER LIDS AND WAS INFORMED THE ITEM IS ON BACK ORDER AT THIS TIME AND COULD NOT BE SHIPPED. ONCE INFORMED OF THE BACK ORDER, THE CUSTOMER REQUESTED EMERGENCY PERMISSION TO REPROCESS AND RE-USE THE SAFE TOUCH COLLECTION SYSTEM (LIDS). THE CUSTOMER WAS INFORMED PER THE INSTRUCTIONS FOR USE THE COLLECTION CANISTERS AND LIDS ARE FOR SINGLE USE ONLY AND SHOULD NOT BE REPROCESSED OR REUSED. DURING A DILATION AND EVACUATION PROCEDURE USING THE "RIGGED" SUCTION SET UP, A PATIENT "NEARLY BLED TO DEATH" DUE TO INADEQUATE SUCTION CREATED BY THE ALTERNATIVE SUCTION SET UP. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13550428 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171440. One submission often covers many models, so check the product and lot details in each record.

• Z-0078-2023 · Sep 16, 2022 · Open, Classified
  Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.