CLICKLINE 30310MDSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551121771), received between Sep 6, 2018 and Mar 23, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionMar 23, 2022Break; Fracture; Break; Fracture

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): PAEDIATRIC CONSULTANT SURGEON WAS DOING THORACIC OESOPHAGEAL DUPLICATION CYST RESECTION VIA THORACOTOMY APPROACH DURING SURGERY. SURGEON WAS USING FORCEPS KELLY DISSECTING & GRASPING 3MM. SOMEHOW, WHEN SURGEON TRED TO TAKE FORCEPS KELLY OUT, IT WAS NOT COMING THROUGH 3MM TROCAR. SO SURGEON MADE AN INCISION BIGGER AND REMOVED THE FORCEPS. WHEN THE FORCEPS OUT, SCRUB NURSE NOTICED SCREW IS MISSING FROM THE FORCEPS AND INFORMED THE SURGEON. DID X-RAY TO PATIENT, NOTHING FOUND. THE PATIENT CONDITION POST-OP WAS OKAY. (MFR'S. INTERNAL COMPLAINT #(B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869693 ↗
• MalfunctionFeb 28, 2022Scratched Material; Insufficient Device Problem Information; Material Split, Cut or Torn; Scratched Material; Insufficient Device Problem Information; Material Split, Cut or Torn

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): ACCORDING TO THE RECEIVED INFORMATION, WHEN TRYING TO PULL OUT THE FORCEPS (ART. 30310MDS), SOME RESISTANCE WAS FELT. AFTER THAT, IT WAS FOUND THAT A PART OF THE OUTER SHEATH MATERIAL WAS DAMAGED. THE PART OF THE DAMAGED MATERIAL WAS NOT FOUND YET. IT WAS STATED THAT AT PRESENT, THE PATIENT IS IN GOOD CONDITION. BASED ON THE INFORMATION AVAILABLE SO FAR, THERE COULD BE A RISK OF A FOREIGN BODY LEFT IN THE PATIENT. SO, THERE IS NOT YET ENOUGH INFORMATION AVAILABLE TO CLASSIFY THE HEALTH IMPACT OR IF ANY OCCURRED. (MFR'S. INTERNAL COMPLAINT (B)(4)).

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

  MAUDE report 13625182 ↗
• MalfunctionJan 26, 2021Material Integrity Problem; Material Integrity Problem

  PER MEDWATCH REPORT #(B)(4), AND PER OUR CUSTOMER, DURING A THORACOSCOPIC SUTURE ADJUSTMENT PROCEDURE, A PIECE OF INSULATION WAS FOUND FROM A PREVIOUS THORACOSCOPY CASE AND WAS FOUND IN THE PATIENT'S CHEST. IT WAS NOT RECOGNIZED AS INSULATION AT FIRST, SO A SEARCH WAS DONE AND THE INSTRUMENT WAS FOUND IN A REPAIR BIN. THE PIECE OF INSULATION RETRIEVED FROM THE PATIENT MATCHED THE MISSING INSULATION ON THE INSTRUMENT. NO PATIENT HARM REPORTED.

  Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem

  MAUDE report 11232968 ↗
• MalfunctionSep 6, 2018Break; Material Fragmentation; Material Frayed; Scratched Material; Device Fell; Material Frayed; Scratched Material

  WE LEARNED FROM MEDWATCH REPORT #MW5078564 RECEIVED VIA MAIL ON (B)(6) 2018 THAT, ALLEGEDLY, DURING A PROCEDURE ON (B)(6) 2018, THE DISSECTING/GRASPING FORCEPS BROKE AND PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS A FOWLER-STEPHENS ORCHIOPEXY PROCEDURE. AN X-RAY TAKEN WAS NEGATIVE AND CUSTOMER CONFIRMED THE PATIENT WAS FINE POST-OP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7851272 ↗