GAMMA FINDER® IIIRecalls & reported problems
W.O.M. World of Medicine GmbH · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 04056702007973), received between Oct 25, 2024 and Oct 25, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Reprocessing Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Reprocessing Problem1
- Insufficient Device Problem Information1
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.
MalfunctionOct 25, 2024Device Reprocessing Problem; Insufficient Device Problem Information; Device Reprocessing Problem; Insufficient Device Problem Information
1. THE GAMMA FINDER III IS A CRITICAL DEVICE THAT COMES INTO CONTACT WITH STERILE TISSUES/PLACED INSIDE THE PATIENT DURING OPERATIVE PROCEDURES. CRITICAL DEVICES REQUIRE STERILIZATION. (CDC - SPAULDING CLASSIFICATION) OR AT A MINIMUM, HIGH-LEVEL DISINFECTION AND THE USE OF A STERILE SHEATH IF THE DEVICE IS UNABLE TO BE STERILIZED. 2. A STERILE SHEATH IS USED TO COVER THE DEVICE DURING USE, HOWEVER: A. FDA STATES THE USE OF A STERILE COVER DOES NOT CHANGE SPAULDING CLASSIFICATION AND CONSEQUENTLY, THE LEVEL OF DISINFECTION/STERILIZATION REQUIRED. B. REPORTS FROM OR STAFF INDICATE THAT THE STERILE COVERS OFTEN FAIL AND BLOOD IS SEEN INSIDE THE STERILE COVER WHEN REMOVED FROM THE PATIENT 3. OUR ORGANIZATION IS JOINT COMMISSION ACCREDITED AND IF A SURVEYOR WERE TO OBSERVE OR ASK ABOUT THIS DEVICE AND OUR ORGANIZATION WAS FOLLOWING THE IFU AS WRITTEN, THIS WOULD BE AN IMMEDIATE THREAT TO HEALTH AND SAFETY (ITHS) AND COULD AFFECT OUR HOSPITAL'S ACCREDITATION STATUS AND REIMBURSEMENT. THE GAMMA FINDER III IFUS ONLY PRESCRIBE LOW-LEVEL DISINFECTION FOR THIS DEVICE. I AM REQUESTING CLEAR DIRECTIONS FROM THE MANUFACTURER ON THE PROPER CLEANING ACCORDING TO THE CDC/SPAULDING CLASSIFICATION/FD
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20531867 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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