CLICKLINE 33121Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04048551001097), received between Aug 28, 2025 and Jun 10, 2026 — classified as 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Break

  IT WAS REPORTED THAT HANDLES WITH THE CAUTERY POST BROKEN OFF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461995 ↗
• MalfunctionJun 10, 2026Break

  IT WAS REPORTED THAT HANDLES WITH THE CAUTERY POST BROKEN OFF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461994 ↗
• MalfunctionJan 30, 2026Material Fragmentation

  IT WAS REPORTED THAT "DURING A SURGICAL GYNAECOLOGY LAPAROSCOPIC PROCEDURE, A PIECE OF THE NON-RATCHET HANDLE SNAPPED OFF AND FELL ONTO THE PATIENT. SURGEON MANAGED TO OBTAIN THIS AND GIVE TO THE SCRUB NURSE. ANOTHER NON-RATCHET HANDLE WAS ASSEMBLED AND THE PROCEDURE CARRIED ON. NURSE IN CHARGE INFORMED. STERILE SERVICES TO BE INFORMED. A REPLACEMENT HANDLE TO BE SOURCED. PATIENT WAS NOT HARMED - ALTERNATIVE INSTRUMENTATION SOURCED AND PROCEDURE COMPLETED WITHOUT FURTHER EVENT." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225425 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT THE CAUTERY POST BROKE WHEN THE CAUTERY CORD WAS ATTACHED TO THE HANDLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078823 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT THE CAUTERY POST BROKE WHEN THE CAUTERY CORD WAS ATTACHED TO THE HANDLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078821 ↗
• MalfunctionJan 12, 2026Detachment of Device or Device Component

  IT HAS BEEN REPORTED THE CAUTERY POST BROKE WHEN THE CAUTERY CORD WAS ATTACHED TO THE HANDLE. NO PATIENT INJURY OCCURRED, AND THE HANDLES WERE REPLACED SO THE PROCEDURES COULD CONTINUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045658 ↗
• MalfunctionJan 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ROTATING KNOB DETACHED FROM ITS BASE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24040362 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT THE CAUTERY POST BROKE WHEN THE CAUTERY CORD WAS ATTACHED TO THE HANDLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2026-00021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039349 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT THE CAUTERY POST BROKE WHEN THE CAUTERY CORD WAS ATTACHED TO THE HANDLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2026-00023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039341 ↗
• InjuryAug 28, 2025Electrical /Electronic Property Problem; Arcing; Device Damaged by Another Device; Excessive Heating; Electrical /Electronic Property Problem; Arcing; Device Damaged by Another Device; Excessive Heating

  THE FOLLOWING WAS REPORTED: DURING SURGERY, THE PHYSICIAN GOT A SLIGHT BURN ON THE HAND WHILE USING OUR CLICKLINE INSTRUMENTS IN CONJUNCTION WITH MONOPOLAR CURRENT. THE CUSTOMER USES OUR HANDLE 33121 IN COMBINATION WITH THE MONOPOLAR CABLE 20192-104 FROM ERBE MEDIZINTECHNIK. WHEN THE CABLE IS PLUGGED IN, IT DOES NOT CLOSE TIGHTLY, LEAVING A SMALL GAP. THE INJURY OCCURRED DURING SPRAY COAGULATION, WHICH REQUIRES A RELATIVELY HIGH VOLTAGE. CROSS REFERENCE MDR: 9610617-2025-01486, 9610617-2025-01497, 9610617-2025-01499.

  Patient problems: Burn(s)

  MAUDE report 22919595 ↗
• InjuryAug 28, 2025Electrical /Electronic Property Problem; Arcing; Device Damaged by Another Device; Excessive Heating; Electrical /Electronic Property Problem; Arcing; Device Damaged by Another Device; Excessive Heating

  THE FOLLOWING WAS REPORTED: DURING SURGERY, THE PHYSICIAN GOT A SLIGHT BURN ON THE HAND WHILE USING OUR CLICKLINE INSTRUMENTS IN CONJUNCTION WITH MONOPOLAR CURRENT. THE CUSTOMER USES OUR HANDLE 33121 IN COMBINATION WITH THE MONOPOLAR CABLE 20192-104 FROM ERBE MEDIZINTECHNIK. WHEN THE CABLE IS PLUGGED IN, IT DOES NOT CLOSE TIGHTLY, LEAVING A SMALL GAP. THE INJURY OCCURRED DURING SPRAY COAGULATION, WHICH REQUIRES A RELATIVELY HIGH VOLTAGE. CROSS REFERENCE MDR: 9610617-2025-01497, 9610617-2025-01498, 9610617-2025-01499.

  Patient problems: Burn(s)

  MAUDE report 22919593 ↗
• InjuryAug 28, 2025Electrical /Electronic Property Problem; Excessive Heating; Electrical /Electronic Property Problem; Excessive Heating

  THE FOLLOWING WAS REPORTED: DURING SURGERY, THE PHYSICIAN GOT A SLIGHT BURN ON THE HAND WHILE USING OUR CLICKLINE INSTRUMENTS IN CONJUNCTION WITH MONOPOLAR CURRENT. THE CUSTOMER USES OUR HANDLE 33121 IN COMBINATION WITH THE MONOPOLAR CABLE (B)(6) FROM ERBE MEDIZINTECHNIK. WHEN THE CABLE IS PLUGGED IN, IT DOES NOT CLOSE TIGHTLY, LEAVING A SMALL GAP. THE INJURY OCCURRED DURING SPRAY COAGULATION, WHICH REQUIRES A RELATIVELY HIGH VOLTAGE. CROSS REFERENCE MDR: 9610617-2025-01497. 9610617-2025-01498. 9610617-2025-01499.

  Patient problems: Burn(s)

  MAUDE report 22919592 ↗
• InjuryAug 28, 2025Electrical /Electronic Property Problem; Arcing; Device Damaged by Another Device; Excessive Heating; Electrical /Electronic Property Problem; Arcing; Device Damaged by Another Device; Excessive Heating

  THE FOLLOWING WAS REPORTED: DURING SURGERY, THE PHYSICIAN GOT A SLIGHT BURN ON THE HAND WHILE USING OUR CLICKLINE INSTRUMENTS IN CONJUNCTION WITH MONOPOLAR CURRENT. THE CUSTOMER USES OUR HANDLE 33121 IN COMBINATION WITH THE MONOPOLAR CABLE 20192-104 FROM ERBE MEDIZINTECHNIK. WHEN THE CABLE IS PLUGGED IN, IT DOES NOT CLOSE TIGHTLY, LEAVING A SMALL GAP. THE INJURY OCCURRED DURING SPRAY COAGULATION, WHICH REQUIRES A RELATIVELY HIGH VOLTAGE. CROSS REFERENCE MDR: 9610617-2025-01486, 9610617-2025-01497, 9610617-2025-01498.

  Patient problems: Burn(s)

  MAUDE report 22919591 ↗
• InjuryAug 28, 2025Electrical /Electronic Property Problem; Arcing; Device Damaged by Another Device; Excessive Heating; Electrical /Electronic Property Problem; Arcing; Device Damaged by Another Device; Excessive Heating

  THE FOLLOWING WAS REPORTED: DURING SURGERY, THE PHYSICIAN GOT A SLIGHT BURN ON THE HAND WHILE USING OUR CLICKLINE INSTRUMENTS IN CONJUNCTION WITH MONOPOLAR CURRENT. THE CUSTOMER USES OUR HANDLE 33121 IN COMBINATION WITH THE MONOPOLAR CABLE (B)(6) FROM ERBE MEDIZINTECHNIK. WHEN THE CABLE IS PLUGGED IN, IT DOES NOT CLOSE TIGHTLY, LEAVING A SMALL GAP. THE INJURY OCCURRED DURING SPRAY COAGULATION, WHICH REQUIRES A RELATIVELY HIGH VOLTAGE. CROSS REFERENCE MDR: 9610617-2025-01486. 9610617-2025-01497. 9610617-2025-01499.

  Patient problems: Burn(s)

  MAUDE report 22919590 ↗
• InjuryAug 28, 2025Electrical /Electronic Property Problem; Excessive Heating; Electrical /Electronic Property Problem; Excessive Heating

  THE FOLLOWING WAS REPORTED: DURING SURGERY, THE PHYSICIAN GOT A SLIGHT BURN ON THE HAND WHILE USING OUR CLICKLINE INSTRUMENTS IN CONJUNCTION WITH MONOPOLAR CURRENT. THE CUSTOMER USES OUR HANDLE 33121 IN COMBINATION WITH THE MONOPOLAR CABLE 20192-104 FROM (B)(6). WHEN THE CABLE IS PLUGGED IN, IT DOES NOT CLOSE TIGHTLY, LEAVING A SMALL GAP. THE INJURY OCCURRED DURING SPRAY COAGULATION, WHICH REQUIRES A RELATIVELY HIGH VOLTAGE. CROSS REFERENCE MDR: 9610617-2025-01486. 9610617-2025-01497. 9610617-2025-01498.

  Patient problems: Burn(s)

  MAUDE report 22919589 ↗
• MalfunctionAug 28, 2025Electrical /Electronic Property Problem; Arcing; Device Damaged by Another Device; Excessive Heating; Electrical /Electronic Property Problem; Arcing; Device Damaged by Another Device; Excessive Heating

  THE FOLLOWING WAS REPORTED: DURING SURGERY, THE PHYSICIAN GOT A SLIGHT BURN ON THE HAND WHILE USING OUR CLICKLINE INSTRUMENTS IN CONJUNCTION WITH MONOPOLAR CURRENT. THE CUSTOMER USES OUR HANDLE 33121 IN COMBINATION WITH THE MONOPOLAR CABLE (B)(4) FROM ERBE MEDIZINTECHNIK. WHEN THE CABLE IS PLUGGED IN, IT DOES NOT CLOSE TIGHTLY, LEAVING A SMALL GAP. THE INJURY OCCURRED DURING SPRAY COAGULATION, WHICH REQUIRES A RELATIVELY HIGH VOLTAGE. CROSS REFERENCE MDR: 9610617-2025-01486, 9610617-2025-01498, 9610617-2025-01499.

  Patient problems: Burn(s)

  MAUDE report 22919588 ↗
• InjuryAug 28, 2025Electrical /Electronic Property Problem; Excessive Heating; Electrical /Electronic Property Problem; Excessive Heating

  THE FOLLOWING WAS REPORTED: DURING SURGERY, THE PHYSICIAN GOT A SLIGHT BURN ON THE HAND WHILE USING OUR CLICKLINE INSTRUMENTS IN CONJUNCTION WITH MONOPOLAR CURRENT. THE CUSTOMER USES OUR HANDLE 33121 IN COMBINATION WITH THE MONOPOLAR CABLE (B)(6) FROM ERBE MEDIZINTECHNIK. WHEN THE CABLE IS PLUGGED IN, IT DOES NOT CLOSE TIGHTLY, LEAVING A SMALL GAP. THE INJURY OCCURRED DURING SPRAY COAGULATION, WHICH REQUIRES A RELATIVELY HIGH VOLTAGE. CROSS REFERENCE MDR: 9610617-2025-01486. 9610617-2025-01498. 9610617-2025-01499.

  Patient problems: Burn(s)

  MAUDE report 22919587 ↗