CLICKLINE 33310MLRecalls & reported problems
Karl Storz GmbH & Co. KG · CLICKLINE Forceps Insert · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04048551134443), received between Sep 25, 2023 and Jun 10, 2026 — classified as 2 injuries, 3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Insufficient Device Problem Information2
- Detachment of Device or Device Component1
- Fracture1
- Material Fragmentation1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Bowel Burn2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2026Fracture
IT WAS REPORTED THAT AT 14:45 ON (B)(6) 2026, THE PATIENT UNDERWENT LAPAROSCOPIC SALPINGECTOMY AND PARTIAL OOPHORECTOMY UNDER GENERAL ANESTHESIA. AT 16:30, THE TIP OF THE DISSECTING FORCEPS FRACTURED WHEN THE SURGEON RETRIEVED SPECIMENS. THE FRACTURED TIP WAS IMMEDIATELY LOCATED AND REMOVED VIA LAPAROSCOPE. THE TIP WAS INTACT, AND NO FOREIGN BODY REMAINED IN THE ABDOMINAL CAVITY AFTER EXPLORATION. THE INSTRUMENT WAS REPLACED PROMPTLY AND THE OPERATION CONTINUED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25462317 ↗InjuryMar 9, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT DURING LAPAROSCOPIC SURGERY FOR THE TREATMENT OF ENDOMETRIOSIS, A UNIPOLAR HIGH FREQUENCY CORD WAS ATTACHED TO THE HANDLE FOR USE WITH A MARYLAND GRASPER. THE METAL JAWS WERE APPLIED TO TISSUE DEEP WITHIN THE UTERO PELVIC REGION, AND THE SURGEONS ENSURED THAT NO SURROUNDING STRUCTURES WERE INVOLVED BEFORE APPLYING COAGULATION. CROSS REFERENCE MDR: 9610617-2026-00499, 9610617-2026-00500.
Patient problems: Bowel Burn
MAUDE report 24553366 ↗InjuryMar 9, 2026Use of Device Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING LAPAROSCOPIC SURGERY FOR THE TREATMENT OF ENDOMETRIOSIS, A UNIPOLAR HIGH FREQUENCY CORD WAS ATTACHED TO THE HANDLE FOR USE WITH A MARYLAND GRASPER. THE METAL JAWS WERE APPLIED TO TISSUE DEEP WITHIN THE UTERO PELVIC REGION, AND THE SURGEONS ENSURED THAT NO SURROUNDING STRUCTURES WERE INVOLVED BEFORE APPLYING COAGULATION. CROSS REFERENCE MDR: 9610617-2026-00499; 9610617-2026-00500.
Patient problems: Bowel Burn
MAUDE report 24553363 ↗MalfunctionJul 9, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE CUSTOMER RETURNED THE PRODUCT WITHOUT FAILURE DESCRIPTION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. DURING TECHNICAL INSPECTION IT WAS NOTICED THAT THE JAW IS BROKEN AND A PART IS MISSING. THE CUSTOMER WAS ASKED TO CONFIRM WHEN EXACTLY THE DEFECT WAS DETECTED AND WHETHER THERE WAS A RISK THAT THE MISSING PART REMAINED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22462531 ↗MalfunctionSep 25, 2023Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE INSERT KELLY GRASPING FORCEPS, JAWS PART BROKE DURING OPERATION KELLY INSERT GRASPING FORCEPS WAS BROKEN DURING THE OPERATION, SURGEON LUCKILY FIND THE BROKEN PARTS IN THE ABDOMEN AND COULD BE REMOVED VIA THE TROCAR OPENING. NO INJURIES ON PATIENT, ONLY DELAY IN OPERATING TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17808862 ↗
Other Laparoscope, general & plastic surgery devices
- HIGH DEFINITION LCD MONITOR OEV262HOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,937 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-12EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,886 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,086 reports
- Auto Suture OMS-T10BTCovidien LP · Laparoscope, general & plastic surgery1 recall955 reports
- PDB OMS-PDB1000Covidien LP · Laparoscope, general & plastic surgery859 reports
- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Olympus Medical Systems Corp. · Laparoscope, general & plastic surgery777 reports
- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
- Spacemaker SMBTTRNDXCovidien LP · Laparoscope, general & plastic surgery590 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page