NA 837800Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207040003), 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

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 1418479-2021-00013 AND 1418479-2021-00014. RWMIC MDR AWARENESS DATE: 15-MAR-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675796 ↗
• MalfunctionJun 27, 2019Misconnection; Misconnection

  ON JUNE 04, 2019, RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A REPORT FROM A NON-PROFIT ORGANIZATION, (B)(6), REGARDING A USER FACILITY THAT HAD EXPERIENCED AN ISSUE WITH THE UTERINE MANIPULATOR. IT WAS REPORTED THAT A DAY AFTER A PROCEDURE, IT WAS FOUND THAT THE ACORN TIP HAD BEEN RETAINED INSIDE THE PATIENT. UPON FOLLOWING UP WITH THE USER FACILITY THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: "PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR LAPAROTOMY FOR ECTOPIC PREGNANCY. THE SURGEON USED A COHEN UTERINE MANIPULATOR DEVICE. AFTER SURGERY WAS COMPLETED THE SURGEON REMOVED THE COHEN DEVICE AND PLACED IT ON THE BACK TABLE. COUNTS WERE DONE BUT COHEN DEVICE WAS NOT COUNTED SINCE IT CAME IN PEEL PACK. THE PATIENT WAS TAKEN TO THE UNIT, THE FOLLOWING MORNING THE PATIENT WENT TO USE THE BATHROOM TO VOID AND THAT'S WHEN THE ACORN TIP FROM THE COHEN DEVICE HAD DROPPED IN THE TOILET. THE OB SURGEON ON DUTY AT THE TIME, EXAMINE THE PATIENT AND TOOK X-RAYS TO MAKE SURE NO OTHER RETAINED ITEMS. EXAM AND X-RAY WERE CLEAR AND NO HARM TO THE PATIENT."

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 8741135 ↗