n.a. 11582MRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04048551051863), received between Feb 15, 2017 and Jan 3, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (3 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2025Break; Break

  IT WAS REPORTED THAT THE DURING A SIALOENDOSCOPY A BREAKAGE OCCURRED. FOREIGN MATERIAL WAS LEFT INSIDE THE PATIENT. NO HARM TO PATIENT, USER OR THIRD REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074387 ↗
• InjuryJan 3, 2025Break; Break

  IT WAS REPORTED THAT THE DURING A SIALOENDOSCOPY A BREAKAGE OCCURRED. FOREIGN MATERIAL WAS LEFT INSIDE THE PATIENT. NO HARM TO PATIENT, USER OR THIRD REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074386 ↗
• InjuryDec 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT BENDING NOT ABLE TO GO ALL THE WAY THROUGH, TOO THIN. HAPPENED DURING A CASE. SURGEON WAS NOT ABLE TO COMPLETE THE PROCEDURE, CROSS REFERENCE MDR: 9610617-2024-00505.

  Patient problems: Insufficient Information

  MAUDE report 20916325 ↗
• InjuryDec 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT BENDING NOT ABLE TO GO ALL THE WAY THROUGH, TOO THIN. HAPPENED DURING A CASE. SURGEON WAS NOT ABLE TO COMPLETE THE PROCEDURE, CROSS REFERENCE MDR: 9610617-2024-00505.

  Patient problems: Insufficient Information

  MAUDE report 20916029 ↗
• InjuryDec 12, 2024Stretched; Deformation Due to Compressive Stress; Stretched; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT BENDING NOT ABLE TO GO ALL THE WAY THROUGH, TOO THIN. IT WAS NOT POSSIBLE TO COMPLETE THE PROCEDURE WITH THE USE OF THE STONE EXTRACTOR AS INTENDED. AN INCISION WAS MADE TO REMOVE THE STONE. CROSS REFERENCE MDR: 9610617-2024-00499.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915537 ↗
• InjuryDec 12, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT BENDING NOT ABLE TO GO ALL THE WAY THROUGH, TOO THIN. IT WAS NOT POSSIBLE TO COMPLETE THE PROCEDURE WITH THE USE OF THE STONE EXTRACTOR AS INTENDED. AN INCISION WAS MADE TO REMOVE THE STONE. CROSS REFERENCE MDR: 9610617-2024-00499.

  Patient problems: Insufficient Information

  MAUDE report 20915301 ↗
• InjuryFeb 15, 2017Entrapment of Device; Difficult to Remove; Material Separation; Entrapment of Device; Difficult to Remove; Material Separation

  DURING THE SIALOENDOSCOPY PROCEDURE MULTIPLE STORZ STONE EXTRACTOR BASKETS WERE USED TO ATTEMPT TO EXTRACT A STONE THAT WAS LODGED IN A SALIVARY GLAND DUCT. THE BASKETS (REF #S 11575L, 11575K, 11582M) WERE ALL BROKEN AT SOME POINT DURING THE PROCEDURE WHETHER THEY WERE OPENED AROUND THE STONE OR JUST FROM SIMPLY BEING OPENED AND CLOSED ACCORDING TO THE PHYSICIAN WHO WAS PERFORMING THE PROCEDURE. DURING ONE OF THE ATTEMPTS TO EXTRACT A STONE BASKET WHICH WAS OPENED AROUND THE STONE BROKE OFF FROM THE REST OF THE DEVICE AND WAS LEFT AROUND THE STONE AND LODGED IN PLACE MAKING IT IRRETRIEVABLE. MANY ATTEMPTS WERE MADE TO RETRIEVE THE STONE AND THE BASKET AROUND THE STONE, BUT WERE UNSUCCESSFUL. SOME OF THE BASKETS WERE LEFT RETAINED INSIDE THE SALIVARY GLAND DUCT. OVERALL, 8 BASKETS WERE BROKEN IN SOME FASHION DURING THE COURSE OF THIS PROCEDURE. THERE WERE 8 STONE EXTRACTOR BASKETS USED AND ALL 8 FAILED.

  Patient problems: Device Embedded In Tissue or Plaque; Discomfort; Foreign Body In Patient

  MAUDE report 6361354 ↗
• InjuryFeb 15, 2017Entrapment of Device; Difficult to Remove; Material Separation; Entrapment of Device; Difficult to Remove; Material Separation

  DURING THE SIALOENDOSCOPY PROCEDURE MULTIPLE STORZ STONE EXTRACTOR BASKETS WERE USED TO ATTEMPT TO EXTRACT A STONE THAT WAS LODGED IN A SALIVARY GLAND DUCT. THE BASKETS (REF #S 11575L, 11575K, 11582M) WERE ALL BROKEN AT SOME POINT DURING THE PROCEDURE WHETHER THEY WERE OPENED AROUND THE STONE OR JUST FROM SIMPLY BEING OPENED AND CLOSED ACCORDING TO THE PHYSICIAN WHO WAS PERFORMING THE PROCEDURE. DURING ONE OF THE ATTEMPTS TO EXTRACT A STONE BASKET WHICH WAS OPENED AROUND THE STONE BROKE OFF FROM THE REST OF THE DEVICE AND WAS LEFT AROUND THE STONE AND LODGED IN PLACE MAKING IT IRRETRIEVABLE. MANY ATTEMPTS WERE MADE TO RETRIEVE THE STONE AND THE BASKET AROUND THE STONE, BUT WERE UNSUCCESSFUL. SOME OF THE BASKETS WERE LEFT RETAINED INSIDE THE SALIVARY GLAND DUCT. OVERALL, 8 BASKETS WERE BROKEN IN SOME FASHION DURING THE COURSE OF THIS PROCEDURE. THERE WERE 8 STONE EXTRACTOR BASKETS USED AND ALL 8 FAILED.

  Patient problems: Device Embedded In Tissue or Plaque; Discomfort; Foreign Body In Patient

  MAUDE report 6361350 ↗
• InjuryFeb 15, 2017Entrapment of Device; Difficult to Remove; Material Separation; Entrapment of Device; Difficult to Remove; Material Separation

  DURING THE SIALOENDOSCOPY PROCEDURE MULTIPLE STORZ STONE EXTRACTOR BASKETS WERE USED TO ATTEMPT TO EXTRACT A STONE THAT WAS LODGED IN A SALIVARY GLAND DUCT. THE BASKETS (REF #S 11575L, 11575K, 11582M) WERE ALL BROKEN AT SOME POINT DURING THE PROCEDURE WHETHER THEY WERE OPENED AROUND THE STONE OR JUST FROM SIMPLY BEING OPENED AND CLOSED ACCORDING TO THE PHYSICIAN WHO WAS PERFORMING THE PROCEDURE. DURING ONE OF THE ATTEMPTS TO EXTRACT A STONE BASKET WHICH WAS OPENED AROUND THE STONE BROKE OFF FROM THE REST OF THE DEVICE AND WAS LEFT AROUND THE STONE AND LODGED IN PLACE MAKING IT IRRETRIEVABLE. MANY ATTEMPTS WERE MADE TO RETRIEVE THE STONE AND THE BASKET AROUND THE STONE, BUT WERE UNSUCCESSFUL. SOME OF THE BASKETS WERE LEFT RETAINED INSIDE THE SALIVARY GLAND DUCT. OVERALL, 8 BASKETS WERE BROKEN IN SOME FASHION DURING THE COURSE OF THIS PROCEDURE. THERE WERE 8 STONE EXTRACTOR BASKETS USED AND ALL 8 FAILED.

  Patient problems: Device Embedded In Tissue or Plaque; Discomfort; Foreign Body In Patient

  MAUDE report 6361332 ↗