n.a. 30103M1Recalls & reported problems
Karl Storz GmbH & Co. KG · Multifunctional Valve, size 11 mm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551117613), received between May 9, 2019 and Mar 9, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient2
- Patient Problem/Medical Problem2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT ACCORDING TO THE CUSTOMER, THE SEAL ON THE MULTIFUNCTION VALVE ALLEGEDLY DETACHED AND FELL INTO THE PATIENT. NO HARM TO PATIENT, USER, OR THIRD REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24553069 ↗MalfunctionAug 22, 2019Appropriate Device Problem Term/Code Not Available
PER OUR FACTORY IN (B)(4), THIS EVENT OCCURED WITH OUR CUSTOMER IN EU: "ON (B)(6) 2019 THE LID SCREW OF THE VALVE HAS BEEN FOUND DURING A LAPAROSCOPIC PROCEDURE. THERE HAS BEEN A PREVIOUS LAPAROSCOPIC PROCEDURE ON THE (B)(6) 2019, SO THE HOSPITAL ASSUMES THAT THE SCREW HAS BEEN LOST DURING THAT PROCEDURE. THE SECOND PROCEDURE WAS INDEPENDENT FROM THE INCIDENT AND THE SCREW JUST HAS BEEN FOUND BY FORTUNE".
Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem
MAUDE report 8921567 ↗MalfunctionMay 9, 2019Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, A PATIENT CAME IN COMPLAINING OF PAIN. X-RAY REVEALED A DOME PORTION OF A VALVE DOOR WAS LEFT INSIDE THE PATIENT FROM A SURGERY A YEAR AGO. THE CUSTOMER SUSPECTS IT IS KARL STORZ WASHER OR PLASTIC DOME OFF THE TROCAR, BUT CANNOT CONFIRM.
Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem
MAUDE report 8596678 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 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