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CLICKLINE 33310CRecalls & reported problems

Karl Storz GmbH & Co. KG · CLICKLINE Forceps Insert · Class 2

Quick summary

This Karl Storz CLICKLINE forceps insert is a laparoscopic surgical instrument used in general and plastic surgery. Its 70 reports mostly describe the tip or jaw breaking off or detaching during surgery, sometimes leaving small fragments in the patient that had to be retrieved. The reports include 14 injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
70
Deaths reported
0
Injuries reported
14
Recalls naming it
0

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 04048551134092), received between May 15, 2019 and Jun 18, 2026 — classified as 14 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (21 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.

Reports received per month

Nov 2023: 3 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 4 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 1 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component21
  • Material Separation20
  • Break19
  • Material Fragmentation10
  • Material Integrity Problem4
  • Crack2
  • Fracture2
  • Corroded1

Patient problems

  • No Clinical Signs, Symptoms or Conditions26
  • Insufficient Information19
  • No Consequences Or Impact To Patient10
  • Foreign Body In Patient8
  • Patient Problem/Medical Problem7
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • No Known Impact Or Consequence To Patient2
  • Unspecified Mental, Emotional or Behavioral Problem2

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 18, 2026Detachment of Device or Device Component

    IT WAS REPORTED THAT MISSING/DAMAGED JAWS WERE OBSERVED. A JAW BROKE OFF WHILE IN USE. RETRIEVED MISSING PART. NO APPARENT PATIENT INJURY REPORTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25545335 ↗
  • MalfunctionFeb 16, 2026Detachment of Device or Device Component

    IT WAS REPORTED THAT LAPAROSCOPIC BOWEL INSTRUMENT BROKE INTO PIECES DURING LAPAROSCOPIC ABDOMINAL SURGERY. THE BROKEN COMPONENT WAS REMOVED SUCCESSFULLY FROM PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24354521 ↗
  • InjuryDec 12, 2025Break; Break

    ACCORDING TO THE INFORMATION RECEIVED, DURING A LAPAROSCOPIC BOWEL RESECTION THE TIP OF THE 33310C CLICKLINE FORCEPS INSERT BROKE/CAME OFF. THE BROKEN TIP WAS SUCCESSFULLY RETRIEVED UNDER X-RAY GUIDANCE WITH NO INJURY TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23791640 ↗
  • InjuryDec 12, 2025Break; Break

    ACCORDING TO THE INFORMATION RECEIVED, DURING A LAPAROSCOPIC BOWEL RESECTION THE TIP OF THE 33310C CLICKLINE FORCEPS INSERT BROKE/CAME OFF. THE BROKEN TIP WAS SUCCESSFULLY RETRIEVED UNDER X-RAY GUIDANCE WITH NO INJURY TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23791639 ↗
  • MalfunctionOct 29, 2025Break; Break

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CASE THAT A BOWEL GRASPER JAW BROKE OFF THE DEVICE AND WAS IN THE PATIENT. THE JAW WAS REMOVED AND THE CASE CONTINUED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 23417944 ↗
  • MalfunctionJun 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE END OF THE LAPAROSCOPIC DESOLATER SNAPPED OFF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. THERE IS NO MATERIAL NUMBER GIVEN, IT IS ONLY KNOWN THAT THE INVOLVED DEVICE IS A "LAPAROSCOPIC DESPLANTER". SINCE THE EXACT MATERIAL NUMBER IS UNKNOWN, A FURTHER EVALUATION CANNOT BE CONDUCTED AS IT IS NOT CONFIRMED THAT KARL STORZ IS THE LEGAL MANUFACTURER OF THE DEVICE. DUE TO THE REASONS STATED ABOVE NO FURTHER ASSESSMENT REGARDING REPORTABILITY OBLIGATION POSSIBLE. VERSION BB: DURING FILE REVIEW ON MAY 23, 2025 IT TURNED OUT THAT THE MATERIAL NUMBER IS GIVEN IN THE MEANTIME. THUS, THE DQ MUST BE UPDATED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22124780 ↗
  • MalfunctionMay 30, 2025Break; Material Fragmentation; Break; Material Fragmentation

    IT WAS REPORTED THAT DAMAGE TO THE INSERT WAS NOTICED BY THE MEDICAL DEVICE TECHNICIAN DURING PROCESSING. THE INSTRUMENT HAS BEEN SENT OVER TO SSD (STERILE SERVICES DEPARTMENT) AND IT WAS DISCOVERED THE END TIP HAS BROKEN OFF AND NEITHER THEATRE STAFF OR SSD ARE AWARE OF ITS WHEREABOUTS. IT IS NOT KNOWN IF THIS INSTRUMENT WAS BROKEN DURING A PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 22115439 ↗
  • MalfunctionApr 16, 2025Break; Break

    IT WAS REPORTED THAT A LAP GRASPER SNAPPED DURING A PATIENT PROCEDURE & WAS RETRIEVED BY THE SURGEON. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21852470 ↗
  • MalfunctionMar 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT HEARD A LOUD CLICK AND THEN THE SURGEON REALIZED THAT THE INSTRUMENT WAS BROKEN. HE SEARCHED FOR THE MISSING PIECE; IT WAS INSPECTED BY THE SCRUB NURSE AND CONFIRMED ALL PIECES TO INSTRUMENT WERE PRESENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 21710398 ↗
  • MalfunctionOct 31, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT TIP OF BOWEL GRASPER SNAPPED OFF DURING USE INSIDE THE PATIENT. THEY WERE ABLE TO RETRIEVE IT MUCH QUICKER THAN THE FIRST INCIDENT (B)(6) NOT CAUSING THE PROCEDURE TO BE PROLONGED BY MUCH. THE BROKEN ITEM WAS ABLE TO BE RETRIEVED AND REMOVED FROM THE PATIENT WITHOUT ANY ADDITIONAL PROCEDURE. NO INJURY TO PATIENT OR USER REPORTED. CROSS REFERENCE MDR: 9610617-2024-00432.

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

    MAUDE report 20583156 ↗
  • InjuryOct 31, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

    IT WAS REPORTED THAT TIP OF THE BOWEL GRASPER SNAPPED OFF DURING USE INSIDE A PATIENT. CAUSED THE PROCEDURE TO BE PROLONGED BY 3 HOURS WHILE RETRIEVING SMALL BIT THAT HAD COME OFF. SINCE THE PROCEDURE WAS PROLONGED BY 3 HOURS AND NO INFORMATION IF THE BROKEN PART WAS FULLY RETRIEVED, THIS CASE IS REPORTABLE AS PRECAUTION. CROSS REFERENCE MDR: 9610617-2024-00429.

    Patient problems: Foreign Body In Patient; Insufficient Information

    MAUDE report 20583043 ↗
  • InjuryOct 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT TIP OF THE BOWEL GRASPER SNAPPED OFF DURING USE INSIDE A PATIENT. CAUSED THE PROCEDURE TO BE PROLONGED BY 3 HOURS WHILE RETRIEVING SMALL BIT THAT HAD COME OFF. SINCE THE PROCEDURE WAS PROLONGED BY 3 HOURS AND NO INFORMATION IF THE BROKEN PART WAS FULLY RETRIEVED, THIS CASE IS REPORTABLE AS PRECAUTION CROSS REFERENCE MDR: 9610617-2024-00429.

    Patient problems: Foreign Body In Patient; Insufficient Information

    MAUDE report 20582962 ↗
  • MalfunctionOct 2, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED DURING A PROCEDURE ONE JAW OF THE CLICK LINE FORCEPS DETACHED INSIDE OF THE PATIENT. THE BROKEN JAW WAS SUCCESSFULLY RETRIEVED WITH NO ADVERSE PATIENT EFFECTS. NO DEATH OR UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20355371 ↗
  • MalfunctionDec 19, 2023Break; Break

    IT WAS REPORTED THAT INSERTION OF THE THIRD (LAST) PORT, THE CONSULTANT SURGEON USED THE JOHAN FORCEP TO HOLD THE SHEATH SO THAT HE CAN ADVANCE THE PORT. WHILE THE SURGEON WAS DOING THIS, ONE OF THE JAWS OF THE FORCEP BROKE OFF. ONE JAW WAS COMPLETELY SEPARATED FROM THE OTHER JAW AND WAS MISSING IN THE PERITONEAL AREA. THE MISSING JAW WAS LOCATED AND RETRIEVED BY THE CONSULTANT SURGEON WITHOUT ANY FURTHER PROBLEM AND TIME DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18357814 ↗
  • InjuryNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE INSTRUMENT WAS CHECKED FOR FUNCTIONALITY BEFORE BEING HANDED OVER. NO DAMAGE WAS FOUND. AFTER THE INSTRUMENT WAS INSERTED, THE BRANCH WAS OPENED TO LIFT THE TUBE. THE INSTRUMENT JUMPED OUT OF THE HOLDER AND A METAL SPLITTER FLEW INTO THE FIELD OF VISION. THE GRASPING FORCEPS COULD NO LONGER BE OPENED OR CLOSED USING THE HANDLE. AFTER THE METAL SPLINTER WAS RECOVERED, IT WAS HELD AGAINST THE DEFECTIVE AREA. IT WAS NOTICED THAT THIS WAS ONLY HALF OF AN OTHERWISE CLOSED RING. A LAPAROSCOPIC SEARCH WAS MADE FOR THE MISSING PART. NOTHING WAS FOUND. THE PATIENT'S PELVIS WAS THEN X-RAYED. THERE WERE NO ABNORMALITIES HERE EITHER.

    Patient problems: Insufficient Information

    MAUDE report 18121269 ↗
  • InjuryNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE INSTRUMENT WAS CHECKED FOR FUNCTIONALITY BEFORE BEING HANDED OVER. NO DAMAGE WAS FOUND. AFTER THE INSTRUMENT WAS INSERTED, THE BRANCH WAS OPENED TO LIFT THE TUBE. THE INSTRUMENT JUMPED OUT OF THE HOLDER AND A METAL SPLITTER FLEW INTO THE FIELD OF VISION. THE GRASPING FORCEPS COULD NO LONGER BE OPENED OR CLOSED USING THE HANDLE. AFTER THE METAL SPLINTER WAS RECOVERED, IT WAS HELD AGAINST THE DEFECTIVE AREA. IT WAS NOTICED THAT THIS WAS ONLY HALF OF AN OTHERWISE CLOSED RING. A LAPAROSCOPIC SEARCH WAS MADE FOR THE MISSING PART. NOTHING WAS FOUND. THE PATIENT'S PELVIS WAS THEN X-RAYED. THERE WERE NO ABNORMALITIES HERE EITHER.

    Patient problems: Insufficient Information

    MAUDE report 18120304 ↗
  • MalfunctionNov 1, 2023Material Separation; Material Separation

    IT WAS REPORTED THAT THE END OF THE BOWEL GRASPER BROKE DURING USE INSIDE THE PATIENT'S ABDOMEN. THE BROKEN PART WAS REMOVED, AND NO HARM OCCURRED TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18051738 ↗
  • MalfunctionOct 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE ITEM BROKE DURING A PROCEDURE INSIDE THE PATIENT'S BODY, BUT THE PIECES WERE RETRIEVED WITH ANOTHER GRASPER WITHOUT ANY NEGATIVE IMPACT ON THE PATIENT. THE TECHNICAL EVALUATION CONCLUDED THAT ISSUE (BREAKING OF THE JAWS) MOST LIKELY OCCURRED DUE TO WEAR-AND-TEAR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17901954 ↗
  • InjurySep 29, 2023Break; Break

    IT WAS REPORTED THAT THE "INSTRUMENT PIECES BROKE OFF DURING A CASE". NO HARM TO PATIENT, USER OR THIRD PARTIES REPORTED. HOWEVER, THE FOLLOWING INFORMATION WAS PROVIDED: "SURGEON WAS ABLE TO COMPLETE THE PROCEDURE HOWEVER THEY HAD TO CONVERT TO OPEN TO RETRIEVE THE BROKEN PIECES; THERE WAS NO INJURY TO PATIENT OR CLINICIAN."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17845851 ↗
  • InjurySep 29, 2023Break; Break

    IT WAS REPORTED THAT THE "INSTRUMENT PIECES BROKE OFF DURING A CASE". NO HARM TO PATIENT, USER OR THIRD PARTIES REPORTED. HOWEVER, THE FOLLOWING INFORMATION WAS PROVIDED: "SURGEON WAS ABLE TO COMPLETE THE PROCEDURE HOWEVER THEY HAD TO CONVERT TO OPEN TO RETRIEVE THE BROKEN PIECES; THERE WAS NO INJURY TO PATIENT OR CLINICIAN."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17845846 ↗
  • InjurySep 29, 2023Break; Break

    IT WAS REPORTED THAT THE "INSTRUMENT PIECES BROKE OFF DURING A CASE". NO HARM TO PATIENT, USER OR THIRD PARTIES REPORTED. HOWEVER, THE FOLLOWING INFORMATION WAS PROVIDED: "SURGEON WAS ABLE TO COMPLETE THE PROCEDURE HOWEVER THEY HAD TO CONVERT TO OPEN TO RETRIEVE THE BROKEN PIECES; THERE WAS NO INJURY TO PATIENT OR CLINICIAN."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17845844 ↗
  • InjurySep 29, 2023Break; Break

    IT WAS REPORTED THAT THE "INSTRUMENT PIECES BROKE OFF DURING A CASE". NO HARM TO PATIENT, USER OR THIRD PARTIES REPORTED. HOWEVER, THE FOLLOWING INFORMATION WAS PROVIDED: "SURGEON WAS ABLE TO COMPLETE THE PROCEDURE HOWEVER THEY HAD TO CONVERT TO OPEN TO RETRIEVE THE BROKEN PIECES; THERE WAS NO INJURY TO PATIENT OR CLINICIAN."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17845841 ↗
  • MalfunctionAug 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT PARTS OF THE DEVICE BROKE OFF IN THE PATIENT. THE BROKEN PIECE WAS REMOVED, AND AN X-RAY WAS NOT REQUIRED. TECHNICAL EVALUATION FOUND SCRATCHES ON THE SURFACE NEAR WEAR THE PIECE BROKE OFF AND SLIGHTLY BEND SHAFT THAT MIGHT HAVE LED TO THE BREAKAGE. IN ALL CASES DESCRIBED ABOVE NO PATIENT, USER OR THIRD WAS HARMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17647543 ↗
  • MalfunctionAug 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE JAW BROKE OFF INSIDE OF PATIENT. THE DOCTOR WAS ABLE TO RETRIEVE AND AN X-RAY OR OTHER WAS USED TO CONFIRM THAT ALL PARTS WERE RETRIEVED. THE DAMAGE IS MOST LIKELY THE RESULT OF MISHANDLING BY THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17647418 ↗
  • MalfunctionAug 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE TIP OF LAP GRASPER BROKE DURING PROCEDURE. NO MENTION OF PATIENT HARM, AND THE FACILITY HAS THROWN THE INSTRUMENT AWAY, SO IT CANNOT BE BROUGHT IN FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17647264 ↗

Other Laparoscope, general & plastic surgery devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.