NA 837890Recalls & reported problems
Richard Wolf GmbH · PORTIO CONE ATTACHMENT SZ SMALL for introduction of fluid for hysterosalpingography, curved upwards, compatible with intrauterine probe 8378001, with Luer connection, reusable · Class 2
- 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 04055207040010), received between Jun 27, 2019 and Apr 15, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Body Fluid” (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
- Device Contamination with Body Fluid1
- Failure to Clean Adequately1
- Microbial Contamination of Device1
- Misconnection1
- Residue After Decontamination1
Patient problems
- Exposure to Body Fluids1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2021Microbial Contamination of Device; Device Contamination with Body Fluid; Residue After Decontamination; Failure to Clean Adequately; 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 1418479-2021-00014. RWMIC MDR AWARENESS DATE: 15-MAR-2021.
Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions
MAUDE report 11675818 ↗MalfunctionJun 27, 2019Misconnection; Misconnection
FOLLOW UP 1 TO PROVIDE CORRECTED AND ADDITIONAL INFORMATION.
Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient
MAUDE report 8741136 ↗
Other System, abortion, vacuum devices
All System, abortion, vacuum devices →Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.