n.a. 26173KPLRecalls & reported problems
Karl Storz GmbH & Co. KG · Macro Needle Holder, 5 mm, 33 cm · Class 2
Data updated Oct 13, 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 04048551098233), received between May 4, 2023 and Feb 26, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Material Fragmentation1
Patient problems
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2025Break; Break
IT WAS REPORTED THAT THE PRODUCT HAD "BROKEN JAWS." THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD.
Patient problems: Insufficient Information
MAUDE report 21471623 ↗MalfunctionOct 23, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED DURING A MEDICAL PROCEDURE ON (B)(6) 2024, PIN FELL OUT OF THE DISTAL END OF THE INSTRUMENT. THEY ARE NOT SURE IF THE PIN FELL OUT BEFORE THE INSTRUMENT WAS BROUGHT INTO THE SURGERY OR IF IT FELL OUT DURING THE CASE. HOWEVER, NO INJURIES WERE REPORTED AND NO SURGICAL DELAYS.
Patient problems: Insufficient Information
MAUDE report 20518946 ↗MalfunctionMay 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WAS A BROKEN TIE ROD. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16868422 ↗
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