CERVICAL SEAL ASSY DEVICE OLK-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15420045512191), received between Feb 4, 2021 and Aug 25, 2026 — classified as 1 injury, 5 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient received on (b)(6) 2026, initially a MyoSure procedure to remove two large fibroids hysteroscopically, then 2 MyoSure reach devices were used and a MyoSure XL device was used to remove calcified parts of the fibroids. A portion of the largest submucosal fibroid was not respected or removed. Then a NovaSure procedure was performed successfully using a concomitant OmniLok to increase the cervical seal. Next 2 large fibroids were removed Laparoscopically followed by Four Acessa fibroid ablation and a Mini Laparotomy procedure was performed to remove the Myomectomy fibroids at the end of the case. The patient was readmitted due to pain post procedure. No other information could be obtained.

  Patient problems: Pain

  MAUDE report 50432449 ↗
• MalfunctionMar 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, UTILIZING THE OMNILOK DEVICE, UPON REMOVING THE DEVICE FROM THE PATIENT THE TIP CAME OFF AND WAS LEFT AT THE END OF THE CERVIX. THE PHYSICIAN REMOVED THE TIP WITH FORCEPS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635630 ↗
• MalfunctionMar 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, UTILIZING THE OMNILOK DEVICE, UPON REMOVING THE DEVICE FROM THE PATIENT THE TIP CAME OFF AND WAS LEFT AT THE END OF THE CERVIX. THE PHYSICIAN REMOVED THE TIP WITH FORCEPS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635607 ↗
• MalfunctionJan 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A OMNI LOK PROCEDURE, THE TIP OF THE DEVICE DISCONNECTED AND FELL INTO THE PATIENT´S CAVITY, IT WAS RECOVERED USING TWEEZERS AND NO PATIENT INJURY WAS REPORTED. THE PROCEDURE WAS COMPLETED AND THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282814 ↗
• MalfunctionFeb 4, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT ON DECEMBER 16TH, WHILE USING A OMNILOK IN A PATIENT, THE TIP OF THE DEVICE CAME OFF THE END AND THE PIECE DISPERSED IN THE THEATRE ROOM. NO IMPACT TO PATIENT OR USER REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11281217 ↗
• MalfunctionFeb 4, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A PROCEDURE THE TIP OF THE OMNILOK CAME OFF AND WAS DIFFICULT TO REMOVE FROM THE CERVIX. NO PATIENT INJURY WAS REPORTED. NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11280725 ↗