V. Mueller GL1600-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403044632), received between Feb 1, 2023 and Feb 1, 2023 — 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.

• MalfunctionFeb 1, 2023Break; Break

  MATERIAL NO: GL1600-003. BATCH NO: G19. IT WAS REPORTED BY THE CUSTOMER THAT PART OF A UTERINE CURRETTE BROKE OFF INSIDE PATIENT. VERBATIM: PART OF A UTERINE CURETTE BROKE OFF INSIDE A PATIENT. 11JAN2023 ADDITIONAL INFORMATION: DO YOU HAVE THE LOT NUMBER? YES, THE LOT NUMBER IS G19. I WAS IN THE HOSPITAL TODAY TO VERIFY THIS ALONG WITH THE PRODUCT CODE. WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? HYSTEROSCOPY + D & C. HOW WAS THE INSTRUMENT RETRIEVED AND WERE ALL PARTS RECOVERED? THE PATIENT HAD BEEN BROUGHT OUT OF SURGERY AND OFF OF ANESTHESIA. AN X-RAY WAS THEN PERFORMED WHERE THEY DISCOVERED THE BROKEN PIECE WAS INSIDE PATIENT. THEY THEN BROUGHT THE PATIENT BACK INTO SURGERY, UNDER ANESTHESIA, AND REMOVED THE PART OF THE CURETTE THAT BROKE OFF. ALL PARTS WERE RECOVERED. WAS THERE A MEDICAL PROCEDURE PERFORMED TO VERIFY IF THE INSTRUMENT WAS IN THE PATIENT¿S BODY, SUCH AS AN X-RAY? YES, AN X-RAY WAS PERFORMED TO VERIFY THAT THE INSTRUMENT PIECE WAS INSIDE THE PATIENT. WHAT WAS THE PATIENT¿S OUTCOME? PATIENT WAS FINE/HAD NO ISSUES AND WAS DISCHARGED THE SAME DAY. WAS THE PROCEDURE COMPLETED AS PLANNED? YES, THE PROCEDURE WAS COMPLETED AS PLANNED. DO YOU HAVE PHOTOS OF THE REP

  Patient problems: Foreign Body In Patient

  MAUDE report 16279916 ↗