CLICKLINE 33300Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 04048551002308), received between Feb 17, 2017 and Jun 10, 2026 — classified as 34 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Material Separation

  IT WAS REPORTED THAT INSULATION IS PEELING OFF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461996 ↗
• MalfunctionApr 2, 2026Material Separation

  IT WAS REPORTED THAT THE PRODUCT PEELED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24769448 ↗
• MalfunctionApr 1, 2026Material Separation

  IT WAS REPORTED THAT THE PRODUCT PEELED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24760426 ↗
• MalfunctionApr 1, 2026Material Separation

  IT WAS REPORTED THAT THE PRODUCT PEELED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24759844 ↗
• MalfunctionFeb 26, 2026Break

  THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION ABOUT THE DEFECT OR MALFUNCTION. ACCORDING TO THE INVESTIGATION RESULTS: THE PROXIMAL SECTION OF THE SHAFT IS BROKEN. THE BROKEN OFF-PART IS MISSING. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2026-00381.

  Patient problems: Insufficient Information

  MAUDE report 24464279 ↗
• InjuryFeb 12, 2026Material Fragmentation

  IT WAS REPORTED THAT SURGEON USING CLICKLINE DURING PROCEDURE, STOPPED WORKING AND SWAPPED INSTRUMENT OUT AND CARRIED ON WITH PROCEDURE, THEN NOTICED SMALL METAL PIECE INSIDE PATIENT, SUPPOSEDLY END OF 33300 SHEATHS. X-RAY WERE PERFORMED AND THE FRAGMENT WAS REMOVED. DUE TO THE X-RAYS TAKEN, THE CASE IS DEEMED AS REPORTABLE.

  Patient problems: Insufficient Information

  MAUDE report 24328726 ↗
• InjuryJan 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT FRAGMENTS OF THE INSTRUMENT WERE LOST DURING PROCEDURE. POST PROCEDURE X- RAYS WERE PERFORMED TO VERIFY THAT NO FRAGMENTS HAD ENTERED THE PATIENT. THE IMAGING CONFIRMED THAT NO FRAGMENTS WERE RETAINED. SINCE X-RAYS WERE TAKEN, THE CASE IS DEEMED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215231 ↗
• InjuryJan 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT FRAGMENTS OF THE INSTRUMENT WERE LOST DURING PROCEDURE. POST PROCEDURE X- RAYS WERE PERFORMED TO VERIFY THAT NO FRAGMENTS HAD ENTERED THE PATIENT. THE IMAGING CONFIRMED THAT NO FRAGMENTS WERE RETAINED. SINCE X-RAYS WERE TAKEN, THE CASE IS DEEMED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211143 ↗
• InjuryNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, A SMALL PIECE OF METAL WAS DETECTED INSIDE THE PATIENT'S ABDOMEN DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE SURGEON ATTEMPTED TO REMOVE IT; HOWEVER, IT SLIPPED AND COULD NOT BE LOCATED. THE FOLLOWING DAY, THE PATIENT UNDERWENT A CT SCAN AND MRI DUE TO BILIARY PERITONITIS, DURING WHICH THE SMALL PIECE OF METAL WAS IDENTIFIED. THE PATIENT WAS TAKEN BACK TO THEATRE THE NEXT DAY FOR MANAGEMENT OF THE PERITONITIS, AND THE METAL FRAGMENT WAS SUCCESSFULLY REMOVED. SUBSEQUENT INSPECTION OF THE INSTRUMENT TRAY USED DURING THE INITIAL SURGERY.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 23661156 ↗
• InjuryNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, A SMALL PIECE OF METAL WAS DETECTED INSIDE THE PATIENT'S ABDOMEN DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE SURGEON ATTEMPTED TO REMOVE IT; HOWEVER, IT SLIPPED AND COULD NOT BE LOCATED. THE FOLLOWING DAY, THE PATIENT UNDERWENT A CT SCAN AND MRI DUE TO BILIARY PERITONITIS, DURING WHICH THE SMALL PIECE OF METAL WAS IDENTIFIED. THE PATIENT WAS TAKEN BACK TO THEATRE THE NEXT DAY FOR MANAGEMENT OF THE PERITONITIS, AND THE METAL FRAGMENT WAS SUCCESSFULLY REMOVED. SUBSEQUENT INSPECTION OF THE INSTRUMENT TRAY USED DURING THE INITIAL SURGERY.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 23659264 ↗
• MalfunctionNov 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE SURGEON SCRAPED AWAY INSULATION ON TWO SHEATS WITH ANOTHER INSTRUMENT DURING PROCEDURE. THE ISSUE HAPPENED OUTSIDE THE PATIENT. THE SURGERY WAS SUCCESSFULLY FINISHED WITH A PROLONGATION WAS LESS THAN 15 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-02112.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610565 ↗
• MalfunctionNov 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE SURGEON SCRAPED AWAY INSULATION ON TWO SHEATS WITH ANOTHER INSTRUMENT DURING PROCEDURE. THE ISSUE HAPPENED OUTSIDE THE PATIENT. THE SURGERY WAS SUCCESSFULLY FINISHED WITH A PROLONGATION WAS LESS THAN 15 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-02113.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610555 ↗
• InjurySep 3, 2025Crack; Material Fragmentation; Excessive Heating; Crack; Material Fragmentation; Excessive Heating

  ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED THE PATIENT SUFFERED A MINOR BURN DURING THE SURGERY. A TAPP WAS PERFORMED ON THE RIGHT SIDE. A DEFECTIVE OUTER SHAFT WAS USED DURING THE OPERATION. THE INSULATION WAS DAMAGED. THE DEFECTIVE INSULATION CAUSED THE CURRENT TO BE CONDUCTED TO THE TROCAR, RESULTING IN THE BURN. THE SURGERY WAS COMPLETED SUCCESSFULLY AND NO ADDITIONAL MEDICAL INTERVENTIONW AS REQUIRED. ALL IN ALL THERE ARE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 22955872 ↗
• InjurySep 3, 2025Crack; Excessive Heating; Crack; Excessive Heating

  ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED THE PATIENT SUFFERED A MINOR BURN DURING THE SURGERY. A TAPP WAS PERFORMED ON THE RIGHT SIDE. A DEFECTIVE OUTER SHAFT WAS USED DURING THE OPERATION. THE INSULATION WAS DAMAGED. THE DEFECTIVE INSULATION CAUSED THE CURRENT TO BE CONDUCTED TO THE TROCAR, RESULTING IN THE BURN. THE SURGERY WAS COMPLETED SUCCESSFULLY AND NO ADDITIONAL MEDICAL INTERVENTIONW AS REQUIRED. ALL IN ALL THERE ARE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 22955871 ↗
• InjuryAug 5, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE INFORMATION RECEIVED, IT IS SUSPECTED THAT A PORTION OF THE PRODUCT MAY HAVE BROKEN OFF AND MAY REMAIN WITHIN THE PATIENT'S ABDOMINAL CAVITY. X-RAYS AND CT SCANS WERE TAKEN AND WHAT APPEARED TO BE A PART WAS CONFIRMED, BUT IT IS UNCLEAR WHETHER IT IS THE BROKEN PART OF THE PRODUCT IN QUESTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22720837 ↗
• InjuryJul 21, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, IT IS SUSPECTED THAT A PORTION OF THE PRODUCT MAY HAVE BROKEN OFF AND MAY REMAIN WITHIN THE PATIENT'S ABDOMINAL CAVITY. X-RAYS AND CT SCANS WERE TAKEN AND WHAT APPEARED TO BE A PART WAS CONFIRMED, BUT IT IS UNCLEAR WHETHER IT IS THE BROKEN PART OF THE PRODUCT IN QUESTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22554013 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT THE END OF THE OUTER TUBE BROKE WHILST BEING USED IN THEATRE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472976 ↗
• InjuryJul 10, 2025Break; Break

  IT WAS REPORTED THAT THE FORCEPS BROKE DURING A LAPAROSCOPIC PROCEDURE. THE METAL FLAP THAT WAS LOST IN THE PATIENT'S ABDOMEN WAS LOCATED IMMEDIATELY. HOWEVER, FURTHER RADIOLOGICAL EXAMINATIONS WERE NECESSARY TO LOCATE THE METAL FRAGMENTS, WHICH EXPOSED THE PATIENT TO X-RAYS AND EXTENDED HIS GENERAL ANAESTHESIA BY AT LEAST TWO HOURS. THIS DELAYED THE END OF THE OPERATION AND SUBSEQUENT OPERATIONS. AS X-RAYS WERE TAKEN AND FURTHER ANAESTHESIA WAS ADMINISTERED, THE CASE IS DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472385 ↗
• InjuryJul 10, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FORCEPS BROKE DURING A LAPAROSCOPIC PROCEDURE. THE METAL FLAP THAT WAS LOST IN THE PATIENT'S ABDOMEN WAS LOCATED IMMEDIATELY. HOWEVER, FURTHER RADIOLOGICAL EXAMINATIONS WERE NECESSARY TO LOCATE THE METAL FRAGMENTS, WHICH EXPOSED THE PATIENT TO X-RAYS AND EXTENDED HIS GENERAL ANAESTHESIA BY AT LEAST TWO HOURS. THIS DELAYED THE END OF THE OPERATION AND SUBSEQUENT OPERATIONS. AS X-RAYS WERE TAKEN AND FURTHER ANAESTHESIA WAS ADMINISTERED, THE CASE IS DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472380 ↗
• InjuryMay 7, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMERGENCY LAPAROSCOPIC APPENDICECTOMY A SMALL FRAGMENT OF METAL CAME OFF ONE OF THE BLACK INSULATED TUBES FOR A LAPAROSCOPIC GRASPER MID PROCEDURE. A CRACK WAS HEARD, AND A VISIBLE FRAGMENT OF METAL WAS SEEN TO FLY OFF ONTO THE OMENTUM. THE GRASPER WAS REMOVED AND ANOTHER DEVICE WAS USED TO REMOVE THE FRAGMENT OF METAL SAFELY. IT COULD VISIBLY BE SEEN THAT BOTH SMALL METAL FRAGMENTS THAT WOULD NORMALLY SIT AT THE SHOULDER OF THE INSTRUMENT WERE MISSING. THE PROCEDURE IT WAS ESCALATED, AND A FURTHER FLUOROSCOPY WAS TAKEN. THIS LED TO PROLONGED ANAESTHESIA. THE FRAGMENT WAS RETRIEVED BY THE SURGEON, AND IT WAS CONFIRMED BY X-RAY THAT THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT DUE TO THE ADDITIONAL FLUOROSCOPY AND X-RAYS THE EVENT IS DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978417 ↗
• InjuryMar 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, "CALLED IN TO THEATRE FOR AN INSTRUMENT ISSUE, WAS FOUND THAT A CLICKLINE OUTER SHEATH WAS NOT WORKING TO SPECIFICATION DUE TO THE LOCKING COLLAR NOT WORKING. METAL PIECE WAS FOUND IN THE PATIENT WHICH CAME FROM THE END OF THE OUTER SHEATH. METAL PIECE WAS NOT COMPLETE. COORDINATOR INFORMED AND SURGEON INFORMED, X-RAY ORDERED AND PERFORMED".

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21580067 ↗
• InjuryMar 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, "CALLED IN TO THEATRE FOR AN INSTRUMENT ISSUE, WAS FOUND THAT A CLICK LINE OUTER SHEATH WAS NOT WORKING TO SPECIFICATION DUE TO THE LOCKING COLLAR NOT WORKING. METAL PIECE WAS FOUND IN THE PATIENT WHICH CAME FROM THE END OF THE OUTER SHEATH. METAL PIECE WAS NOT COMPLETE. COORDINATOR INFORMED AND SURGEON INFORMED, X-RAY ORDERED AND PERFORMED".

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21580066 ↗
• MalfunctionMar 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BROKE PRIOR TO USE, PROXIMAL END OF SHEATH SNAPPED INSIDE HANDLE. NO PATIENT INVOLVEMENT. BROKEN DURING SET UP FOR PROCEDURE, 2-MINUTE DELAY TO PROCEDURE. NEW SET WAS USED, AND PROCEDURES CONTINUED. SINCE NO PATIENT INVOLVEMENT AND NO INJURY TO PATIENT. CROSS REFERENCE MDR: 9610617-2025-00371.

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

  MAUDE report 21531714 ↗
• InjuryJul 9, 2024Material Disintegration; Material Disintegration

  IT WAS REPORTED ON MAY 18, 2024 THAT DURING A LAPAROSCOPIC APPENDICECTOMY CASE, THE BITS FROM THE INSIDE OF SHEATH OF A SURGICAL INSTRUMENT [ YOHAN] FROM TRAY ACCIDENTLY FELL OFF AND BROKE INTO THE PATIENT ABDOMEN. IT WAS NOTICED IMMEDIATELY AS IT BROKE INTO TWO PIECES. IT WAS RETRIEVED BACK IMMEDIATELY AND TO RE-CONFIRM, AN X-RAY WAS TAKEN AT THE END OF SURGERY BEFORE CLOSURE, NO BITS WERE FOUND INSIDE AND THE WHOLE TEAM WAS HAPPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19703251 ↗
• InjuryJun 14, 2024Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED ON (B)(6) 2024 THAT DURING A LAPAROSCOPIC APPENDICECTOMY CASE, THE BITS FROM THE INSIDE OF SHEATH OF A SURGICAL INSTRUMENT [ YOHAN] FROM TRAY ACCIDENTLY FELL OFF AND BROKE INTO THE PATIENT ABDOMEN. IT WAS NOTICED IMMEDIATELY AS IT BROKE INTO TWO PIECES. IT WAS RETRIEVED BACK IMMEDIATELY AND TO RE-CONFIRM, AN X-RAY WAS TAKEN AT THE END OF SURGERY BEFORE CLOSURE, NO BITS WERE FOUND INSIDE AND THE WHOLE TEAM WAS HAPPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19539116 ↗