ESI 15-4010Recalls & reported problems
Ftt Medical, Inc. · SALVATI OPERATING PROCTOSCOPE, 4CM X 19CM, STAINLESS. ACMI FITTING. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B3961540100), received between Aug 18, 2026 and Aug 18, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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.
Reports received per month
Most reported problems
Device problems
- Defective Device1
- Device Reprocessing Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Device Reprocessing Problem; Use of Device Problem; Defective Device
ESI-ElectroSurgical Instrumest Salvati Proctoscope 15-4010: Multiple product (2)arrived new, was reprocessed once each using manual cleaning with FDA registeredcleaning agent prepared per IFU and AAMI water standards; sent through FDAregistered washer/disinfector using a FDA registered cleaning agent prepared per IFU.All device reprocessing instructions followed as required per the manufacturer IFU.Product was then packaged and sterilized with a STERIS FDA registered autoclave atthe pre-vacuum steam sterilization parameters per the device IFU at 270*F, 4-minuteexposure. Once completed product was opened to be used for a patient procedure andwas found to be defective. The Salvati proctoscope consists of 2 pieces, an innerplastic piece and an outer metal piece. After reprocessing 1-time, the inner plasticpiece could not be assembled into the outer metal piece and unable to be used. Thesurgeon had to used rectal retractor's instead creating a less than ideal surgicalsituation. No harm was done and procedure was completed. A second Salvati waspurchased new and the exact same issue occurred. Both Salvati proctoscopes couldnot be used due to the inner plastic piece not fitting into the o
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50302190 ↗
Other Proctoscope devices
- n.a. 25207Karl Storz GmbH & Co. KG · PROCTOSCOPE1 recall0 reports
- n.a. 24951ONKarl Storz GmbH & Co. KG · PROCTOSCOPE2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.