NA 837891Recalls & reported problems
Richard Wolf GmbH · PORTIO CONE ATTACHMENT SZ LARGE for introduction of fluid for hysterosalpingography, curved upwards, compatible with intrauterine probe 8378001, with Luer connection, reusable · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207040027), received between Jan 27, 2021 and Apr 15, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
Device problems
- Detachment of Device or Device Component1
- Device Contamination with Body Fluid1
- Device Reprocessing Problem1
- Failure to Clean Adequately1
- Microbial Contamination of Device1
- Residue After Decontamination1
Patient problems
- Exposure to Body Fluids1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2021Device Reprocessing Problem; Microbial Contamination of Device; Device Contamination with Body Fluid; Residue After Decontamination; Failure to Clean Adequately; Device Reprocessing Problem; Microbial Contamination of Device; Device Contamination with Body Fluid; Residue After Decontamination; Failure to Clean Adequately
RWMIC REFERENCE COMPLAINT NO. (B)(4). THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE FOLLOWING NEW INFORMATIONS: (SEE H10) RESULTS OF THE DEVICE PRODUCT HISTORY EVALUATION UPDATE/REVISION OF THE ASSOCIATED DEVICE INSTRUCTIONS FOR USE: IFU GA-E074. ALSO, PLEASE SEE RELATED MDR'S 1418479-2021-00012 AND 1418479-2021-00013 RWMIC MDR AWARENESS DATE: 15-MAR-2021.
Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions
MAUDE report 11675791 ↗MalfunctionJan 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
RWMIC RECEIVED MEDWATCH REPORT MW5098196 ON 01/19/2021: PORTIO CONE ATTACHMENT INADVERTENTLY DETACHED FROM UTERINE MANIPULATOR. THIS HAS OCCURRED ON 2 SEPARATE OCCASIONS. IT WAS NOT NOTICED THE FIRST OCCURRENCE AND REMAINED IN THE PATIENT. FDA SAFETY REPORT ID# (B)(4) ON 01/22/2021: SPOKE TO CUSTOMER WHO STATED THAT THIS IS AN ONGOING ISSUE WITH THE CONES BEING LOOSE ON THE HANDLES. PATIENT WENT HOME WITH THE CONE INSIDE AND EXPELLED IT. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? NO. DID THE DELAY PUT THE PATIENT AT RISK? (ONLY APPLICABLE IF THERE WAS A REPORT OF DELAY) N/A. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.
Patient problems: Foreign Body In Patient
MAUDE report 11240176 ↗
Other System, abortion, vacuum devices
All System, abortion, vacuum devices →Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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