CLICKLINE 33510PGRecalls & reported problems
Karl Storz GmbH & Co. KG · Forceps Insert · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551151112), received between May 21, 2024 and Jun 5, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Insufficient Device Problem Information2
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAP CHOLE EMERGENCY PROCEDURE, A CHOLDOSCOPY WAS REQUIRED, USING THE KARL STORZ FLEXIBLE SCOPE. THE GRASPING FORCEPS WERE USED, INCLUDING 2X GRASPING PADS. ONCE USED, ONE OF THE PADS WERE MISSING. IT WAS FOUND IN THE PATIENT PERITONEUM. GRASPING PAD WAS THEN REMOVED BUT PROCEDURE WAS PROLONGED. SINCE MEDICAL/SURGICAL/DIAGNOSTICAL INTERVENTION REQUIRED AND PROCEDURE DELAY 15-60 MINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25417997 ↗InjuryJun 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAP CHOLE EMERGENCY PROCEDURE, A CHOLDOSCOPY WAS REQUIRED, USING THE KARL STORZ FLEXIBLE SCOPE. THE GRASPING FORCEPS WERE USED, INCLUDING 2X GRASPING PADS. ONCE USED, ONE OF THE PADS WERE MISSING. IT WAS FOUND IN THE PATIENT PERITONEUM. GRASPING PAD WAS THEN REMOVED BUT PROCEDURE WAS PROLONGED. SINCE MEDICAL/SURGICAL/DIAGNOSTICAL INTERVENTION REQUIRED AND PROCEDURE DELAY 15-60 MINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25417996 ↗InjuryMay 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE CONSULTANT HAS USED SILICONE PADS ALONG WITH BERCI GRASPING FORCEPS DURING A COMMON BILE DUCT EXPLORATION. CONSULTANT HAS REMOVED THE SCOPE FROM THE PATIENT, WHEN REMOVING THE SILICONE PADS, ONE HAS BOUNCED ACROSS THE ROOM AND BEEN RETRIEVED, AT THIS POINT THE TEAM ARE UNABLE TO LOCATE THE SECOND. THERE ARE NOW CONCERNS THE SECOND ONE HAS BEEN LOST WITHIN THE ABDOMEN. THE CONSULTANT HAS EXPLORED LAPAROSCOPICALLY BUT BEEN UNABLE TO LOCATE OR RETRIEVE THIS ITEM. PATIENT WAS TRANSFERRED TO RECOVERY STABLE NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. SINCE THE LOCATION OF THE SECOND PAD IS UNCLEAR AND THERE IS THE POSSIBILITY THAT IT IS STILL INSIDE THE PATIENT, A REPORT IS REQUIRED.
Patient problems: Foreign Body In Patient
MAUDE report 19361089 ↗InjuryMay 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE CONSULTANT HAS USED SILICONE PADS ALONG WITH BERCI GRASPING FORCEPS DURING A COMMON BILE DUCT EXPLORATION. CONSULTANT HAS REMOVED THE SCOPE FROM THE PATIENT, WHEN REMOVING THE SILICONE PADS, ONE HAS BOUNCED ACROSS THE ROOM AND BEEN RETRIEVED, AT THIS POINT THE TEAM ARE UNABLE TO LOCATE THE SECOND. THERE ARE NOW CONCERNS THE SECOND ONE HAS BEEN LOST WITHIN THE ABDOMEN. THE CONSULTANT HAS EXPLORED LAPAROSCOPICALLY BUT BEEN UNABLE TO LOCATE OR RETRIEVE THIS ITEM. PATIENT WAS TRANSFERRED TO RECOVERY STABLE NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. SINCE THE LOCATION OF THE SECOND PAD IS UNCLEAR AND THERE IS THE POSSIBILITY THAT IT IS STILL INSIDE THE PATIENT, A REPORT IS REQUIRED.
Patient problems: Foreign Body In Patient
MAUDE report 19361088 ↗
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