YANKAUER 0038730Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10653405000631), received between Oct 16, 2023 and Oct 26, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2023Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A NOTICE FROM HEALTH CANADA OF A VIGILANCE REPORT REFERENCE NUMBER (B)(4) RECEIVED ON 18OCT23. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORTED DEVICE WAS THE 0038730, YANKAR STD BULB TIP ON/OFF CTRL W/O VENT. THE DEVICE WAS BEING USED ON (B)(6) 2023 AND ¿SURGERY BEING PERFORMED ON PATIENT. DOCTOR USING YANKAUER SUCTION. THE YANKAUER SUCTION SNAPPED IN HALF WHERE THE CONTROL BUTTON" IS. BOTH PIECES OF THE SINGLE USE STERILE YANKAUER WERE REMOVED FROM STERILE FIELD AND REPLACED WITH A NEW YANKAUER.¿. PER FURTHER ASSESSMENT THE FRAGMENT DID FALL INTO THE SURGICAL SITE AND WAS RETRIEVED.. THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011873 ↗
• MalfunctionOct 16, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, 0038730, YANKAR STD BULB TIP ON/OFF CTRL W/O VENT, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED ¿YANKAUER WAS BEING USED BY DOCTOR- BROKE IN HALF. NURSE IN THE ROOM (NOT THE NURSE REPORTING THIS COMPLAINT) STATED IT HAPPENED 2 OTHER TIMES THIS WEEK IN A DIFFERENT CASE. ALL PIECES LOOK TO BE RECOVERED.¿. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17942259 ↗
• MalfunctionOct 16, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, 0038730, YANKAR STD BULB TIP ON/OFF CTRL W/O VENT, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED ¿YANKAUER WAS BEING USED BY DOCTOR- BROKE IN HALF. NURSE IN THE ROOM (NOT THE NURSE REPORTING THIS COMPLAINT) STATED IT HAPPENED 2 OTHER TIMES THIS WEEK IN A DIFFERENT CASE. ALL PIECES LOOK TO BE RECOVERED.¿. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17942255 ↗
• MalfunctionOct 16, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, 0038730, YANKAR STD BULB TIP ON/OFF CTRL W/O VENT, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿YANKAUER WAS BEING USED BY DOCTOR- BROKE IN HALF. NURSE IN THE ROOM (NOT THE NURSE REPORTING THIS COMPLAINT) STATED IT HAPPENED 2 OTHER TIMES THIS WEEK IN A DIFFERENT CASE. ALL PIECES LOOK TO BE RECOVERED.¿. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17941982 ↗