CLICKLINE 34310MS-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551336410), received between Oct 3, 2019 and Apr 25, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2024Break; Material Fragmentation; Use of Device Problem; Detachment of Device or Device Component; Break; Material Fragmentation; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, AND SENTINEL LYMPH NODE STAGING ON (B)(6) 2023. THE PROCEDURE WAS UNEVENTFUL. HOWEVER, DURING A SURVEILLANCE VISIT WITH THE ONCOLOGIST IN MARCH 2024, THE PATIENT NOTED PERSISTENT RIGHT SIDED PELVIC DISCOMFORT SINCE HER (B)(6) 2023 SURGERY. THE PATIENT THEN HAD AN MRI ON (B)(6) 2024, AND A 3MM METALLIC OBJECT WAS IDENTIFIED IN THE LEFT PELVIS. THERE WAS NO EVIDENCE OF RECURRENT DISEASE. PATIENT THEN UNDERWENT PROCEDURE TO REMOVE THE FRAGMENT ON (B)(6) 2024. THE REMOVED FRAGMENT WAS EXAMINED UNDER DISSECTION SCOPE AND APPEARS CONSISTENT WITH SURGICAL SCISSORS THAT WOULD HAVE BEEN USED DURING LAPAROSCOPIC PROCEDURE BACK IN (B)(6) 2023.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19186678 ↗
• InjuryApr 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, AND SENTINEL LYMPH NODE STAGING ON (B)(6) 2023. THE PROCEDURE WAS UNEVENTFUL. HOWEVER, DURING A SURVEILLANCE VISIT WITH THE ONCOLOGIST IN (B)(6) 2024, THE PATIENT NOTED PERSISTENT RIGHT SIDED PELVIC DISCOMFORT SINCE HER (B)(6) 2023 SURGERY. THE PATIENT THEN HAD AN MRI ON (B)(6) 2024, AND A 3MM METALLIC OBJECT WAS IDENTIFIED IN THE LEFT PELVIS. THERE WAS NO EVIDENCE OF RECURRENT DISEASE. PATIENT THEN UNDERWENT PROCEDURE TO REMOVE THE FRAGMENT ON (B)(6) 2024. THE REMOVED FRAGMENT WAS EXAMINED UNDER DISSECTION SCOPE AND APPEARS CONSISTENT WITH SURGICAL SCISSORS THAT WOULD HAVE BEEN USED DURING LAPAROSCOPIC PROCEDURE BACK IN (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19186670 ↗
• MalfunctionMar 2, 2020Mechanical Jam; Mechanical Jam

  AS PER A VIGILANCE REPORT FILED WITH NATIONAL COMPETENT AUTHORITY, SWISSMEDIC, BY THE FACTORY IN (B)(6): DURING A LAPAROSCOPIC PROCEDURE, THE JAWS OF THE CLICKLINE SCISSORS INSERT COULD NO LONGER BE CLOSED INTRA-ABDOMINALLY. TO REMOVE THE INSTRUMENT, THE TROCAR HAD TO BE REMOVED AND A PAIR OF PLIERS WAS USED TO CLOSE THE JAWS IN ORDER TO BRING THE SCISSORS INSERT THROUGH THE ORIFICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9777546 ↗
• MalfunctionOct 3, 2019Material Separation; Material Separation

  AS PER A VIGILANCE REPORT FILED BY OUR PARENT COMPANY IN (B)(4): BLACK PARTICLE WAS FOUND IN PATIENT DURING SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9154077 ↗