Cook G55477Recalls & reported problems
William A. Cook Australia Pty. Ltd. · Ovum Aspiration Needle, Single Lumen · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002554771), received between Jul 24, 2023 and Aug 2, 2023 — classified as 4 injuries.
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
Device problems
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Hemorrhage/Blood Loss/Bleeding4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TOO MUCH BLEEDING SO THAT PATIENTS ENDED UP GOING TO ER AFTER EGG RETRIEVAL. IT HAPPENED TO TWO PATIENTS IN A ROW ON WEDNESDAY (B)(6) 2023. ((B)(6) PATIENT 1 &(B)(6) PATIENT 2) THE PATIENTS REPORTED TO THE ER WITH PELVIC PAIN, DROP IN HEMATOCRIT AND REQUIRED PAIN MANAGEMENT. NO TRANSFUSION WAS REQUIRED. THE SAME PHYSICIAN PERFORMED BOTH EGG RETRIEVAL PROCEDURES. NO MORE THAN MINIMAL BLEEDING WAS NOTED IMMEDIATELY AFTER EACH SURGERY WAS PERFORMED. NO ABNORMALITY OR DAMAGE TO THE NEEDLES WAS IDENTIFIED ON OPENING, DURING OR AFTER USE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17442636 ↗InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TOO MUCH BLEEDING SO THAT PATIENTS ENDED UP GOING TO EMERGENCY ROOM (ER) AFTER EGG RETRIEVAL. IT HAPPENED TO TWO PATIENTS IN A ROW ON WEDNESDAY (B)(6) 2023. ((B)(4) PATIENT 1 & (B)(4) PATIENT 2) THE PATIENTS REPORTED TO THE ER WITH PELVIC PAIN, DROP IN HEMATOCRIT AND REQUIRED PAIN MANAGEMENT. NO TRANSFUSION WAS REQUIRED. THE SAME PHYSICIAN PERFORMED BOTH EGG RETRIEVAL PROCEDURES. NO MORE THAN MINIMAL BLEEDING WAS NOTED IMMEDIATELY AFTER EACH SURGERY WAS PERFORMED. NO ABNORMALITY OR DAMAGE TO THE NEEDLES WAS IDENTIFIED ON OPENING, DURING OR AFTER USE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17442587 ↗InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TOO MUCH BLEEDING SO THAT PATIENTS ENDED UP GOING TO ER AFTER EGG RETRIEVAL. IT HAPPENED TO TWO PATIENTS IN A ROW ON WEDNESDAY ON (B)(6) 2023. ((B)(6) PATIENT 1 & (B)(6) PATIENT 2) THE PATIENTS REPORTED TO THE ER WITH PELVIC PAIN, DROP IN HEMATOCRIT AND REQUIRED PAIN MANAGEMENT. NO TRANSFUSION WAS REQUIRED. THE SAME PHYSICIAN PERFORMED BOTH EGG RETRIEVAL PROCEDURES. NO MORE THAN MINIMAL BLEEDING WAS NOTED IMMEDIATELY AFTER EACH SURGERY WAS PERFORMED. NO ABNORMALITY OR DAMAGE TO THE NEEDLES WAS IDENTIFIED ON OPENING, DURING OR AFTER USE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17386191 ↗InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TOO MUCH BLEEDING SO THAT PATIENTS ENDED UP GOING TO ER AFTER EGG RETRIEVAL. IT HAPPENED TO TWO PATIENTS IN A ROW ON WEDNESDAY (B)(6) 2023. ((B)(4) PATIENT 1 & (B)(4) PATIENT 2) THE PATIENTS REPORTED TO THE ER WITH PELVIC PAIN, DROP IN HEMATOCRIT AND REQUIRED PAIN MANAGEMENT. NO TRANSFUSION WAS REQUIRED. THE SAME PHYSICIAN PERFORMED BOTH EGG RETRIEVAL PROCEDURES. NO MORE THAN MINIMAL BLEEDING WAS NOTED IMMEDIATELY AFTER EACH SURGERY WAS PERFORMED. NO ABNORMALITY OR DAMAGE TO THE NEEDLES WAS IDENTIFIED ON OPENING, DURING OR AFTER USE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17386057 ↗
Other NEEDLE, ASSISTED REPRODUCTION devices
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- Cook G55253William A. Cook Australia Pty. Ltd. · NEEDLE, ASSISTED REPRODUCTION6 reports
- Cook G55493William A. Cook Australia Pty. Ltd. · NEEDLE, ASSISTED REPRODUCTION4 reports
- Cook G38432William A. Cook Australia Pty. Ltd. · NEEDLE, ASSISTED REPRODUCTION2 reports
- Cook G55788William A. Cook Australia Pty. Ltd. · NEEDLE, ASSISTED REPRODUCTION2 reports
- Cook G55797William A. Cook Australia Pty. Ltd. · NEEDLE, ASSISTED REPRODUCTION1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.