n.a. 11510CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551050958), received between Aug 26, 2022 and Nov 30, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2022Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  THE GRASPER FORCEPS IS USED TO REMOVE A BALLOON INSIDE A FETAL AIRWAY AFTER THE BALLOON IS PUNCTURED. IN THIS CASE THE BALLOON WAS PUNCTURE (NORMAL PRACTICE) BUT BALLOON WAS LEFT IN BECAUSE THE GRASPER WAS BROKEN. BALLOON WILL BE REMOVED ONCE THE FETUS IS DELIVERED BY ENT. POTENTIAL HARM TO FETUS AS FETUS WILL NOW HAVE TO HAVE A PROCEDURE ONCE BORN TO REMOVE THE BALLOON THAT WE WERE NOT ABLE TO REMOVE DUE TO THE BROKEN FORCEPS. THE BROKEN PIECE DID NOT HAPPEN INSIDE THE FETUS BUT IT DID OCCUR INSIDE THE UTERUS AND AMNIOTIC FLUID. X RAYS WERE NOT USED TO VERIFY GRASPER PIECE AS X-RAY'S AREN'T RECOMMENDED IN PREGNANCY. THE GRASPER WAS PROCESSED AS PER CANADIAN HOSPITAL STERILIZATION STANDARDS. THE GRASPER FORCEPS WAS INSERTED INSIDE THE FETAL TRACHEA FOR REMOVAL OF BALLOON, ATTEMPT WAS MADE TO GRASP THE BALLOON BY SURGEON. THE GRASPER WAS REPOSITIONED AND WHEN IT WAS OPENED TO TRY AND GRASP THE BALLOON AGAIN THE LITTLE PIECE BELOW THE TEETH APPEARED TO MALFUNCTION AND WOULD NOT OPEN THE TEETH ON THE GRASPER. GRASPER WAS REMOVED FROM THE UTERUS AND BALLOON WAS PUNCTURE WITH NEEDLE AND LEFT IN. ON INSPECTION AFTER THE PROCEDURE THE GRASPER FORCEPS STILL NOT REOPEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 15889071 ↗
• InjuryNov 30, 2022Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  THE GRASPER FORCEPS IS USED TO REMOVE A BALLOON INSIDE A FETAL AIRWAY AFTER THE BALLOON IS PUNCTURED. IN THIS CASE THE BALLOON WAS PUNCTURE (NORMAL PRACTICE) BUT BALLOON WAS LEFT IN BECAUSE THE GRASPER WAS BROKEN. BALLOON WILL BE REMOVED ONCE THE FETUS IS DELIVERED BY ENT. POTENTIAL HARM TO FETUS AS FETUS WILL NOW HAVE TO HAVE A PROCEDURE ONCE BORN TO REMOVE THE BALLOON THAT WE WERE NOT ABLE TO REMOVE DUE TO THE BROKEN FORCEPS. THE BROKEN PIECE DID NOT HAPPEN INSIDE THE FETUS BUT IT DID OCCUR INSIDE THE UTERUS AND AMNIOTIC FLUID. X RAYS WERE NOT USED TO VERIFY GRASPER PIECE AS X-RAY'S AREN'T RECOMMENDED IN PREGNANCY. THE GRASPER WAS PROCESSED AS PER CANADIAN HOSPITAL STERILIZATION STANDARDS. THE GRASPER FORCEPS WAS INSERTED INSIDE THE FETAL TRACHEA FOR REMOVAL OF BALLOON, ATTEMPT WAS MADE TO GRASP THE BALLOON BY SURGEON. THE GRASPER WAS REPOSITIONED AND WHEN IT WAS OPENED TO TRY AND GRASP THE BALLOON AGAIN THE LITTLE PIECE BELOW THE TEETH APPEARED TO MALFUNCTION AND WOULD NOT OPEN THE TEETH ON THE GRASPER. GRASPER WAS REMOVED FROM THE UTERUS AND BALLOON WAS PUNCTURE WITH NEEDLE AND LEFT IN. ON INSPECTION AFTER THE PROCEDURE THE GRASPER FORCEPS STILL NOT REOPEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 15886114 ↗
• MalfunctionAug 26, 2022Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PER SALESREP WHO WAS NOTIFIED BY THE FACILITY, THAT DURING A FETO BALLOON REMOVAL, ONE OF THE TEETH OF THE FETO GRASPER BROKE OFF INSIDE THE FETUS. A DETAILED SEARCH WITH A FETOSCOPE COULD NOT LOCATE THE PIECE AND IT WAS ASSUMED FLUSHED OUT OF THE FETUS DURING THE PROCEDURE. A FOLLOW UP IS PLANNED ONCE THE BABY IS BORN TO SEE IF TOOTH REMAINS INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300307 ↗