n.a. 8575KARecalls & reported problems
Karl Storz GmbH & Co. KG · Laryngoscope Holder, GÖTTINGEN model · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Karl Storz Göttingen laryngoscope holder holds a rigid laryngoscope in place during procedures. Reports mostly describe the holder jamming during adjustment and metal shavings or debris falling out, including during surgery. There are 26 reports naming its identifier, with no deaths and 2 injuries, and 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
- 31
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04048551210901), received between Sep 27, 2024 and Sep 17, 2026 — classified as 2 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (22 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
- Mechanical Jam22
- Damaged Thread8
- Material Fragmentation4
- Mechanical Problem3
- Insufficient Device Problem Information2
- Break1
- Material Integrity Problem1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Damaged Thread
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812704 ↗MalfunctionSep 17, 2026Damaged Thread
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812703 ↗MalfunctionSep 17, 2026Damaged Thread
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812701 ↗MalfunctionSep 17, 2026Damaged Thread
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812700 ↗MalfunctionSep 17, 2026Damaged Thread
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812699 ↗MalfunctionAug 18, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50304022 ↗MalfunctionApr 24, 2026Mechanical Jam
IT WAS REPORTED THAT METAL SHAVINGS FROM THE LARYNGOSCOPE HOLDER WERE OBSERVED FALLING OUT DURING SURGERY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24987509 ↗MalfunctionApr 24, 2026Mechanical Jam
IT WAS REPORTED THAT METAL SHAVINGS FROM THE LARYNGOSCOPE HOLDER WERE OBSERVED FALLING OUT DURING SURGERY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24986810 ↗MalfunctionApr 3, 2026Mechanical Jam
IT WAS REPORTED THAT DURING THE OPERATION, METAL DEBRIS WAS OBSERVED WHEN THE ADJUSTMENT WHEEL WAS MOVED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775908 ↗MalfunctionMar 10, 2026Mechanical Jam
IT WAS REPORTED THAT THERE WAS OBSERVED A GEAR MALFUNCTION. NO PATIENT INVOLVEMENT REPORTED NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24565649 ↗MalfunctionFeb 2, 2026Break
IT WAS REPORTED THAT THE LARYNGOSCOPE CANNOT BE SUPPORTED BY THE INSTRUMENT. IT BREAKS AFTER BEING USED ONCE OR TWICE. WHEN RESISTANCE IS APPLIED TO THE CHEST SUPPORT, IT JAMS IMMEDIATELY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232835 ↗MalfunctionDec 3, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT METAL SHAVINGS FROM THE LARYNGOSCOPE HOLDER WERE OBSERVED FALLING OUT DURING SURGERY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23710342 ↗MalfunctionDec 2, 2025Mechanical Jam; Mechanical Jam
DURING A ROUTINE CHECK, IT WAS REPORTED THAT THE LARYNGOSCOPE HOLDER BECAME STUCK WHILE BEING ADJUSTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23698772 ↗MalfunctionNov 6, 2025Mechanical Problem; Mechanical Problem
NO DEFECT DESCRIPTION WAS GIVEN BY THE CUSTOMER. TECHNICAL INSPECTION REVEALED CHIP FORMATION AT THE THREAD OF THE LARYNGOSCOPE HOLDER. ACCORDING TO THE EVENT DESCRIPTION THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. SINCE THE RISK ANALYSIS IS BASED TO PATIENT, USER OR THIRD PARTY HARMS NO RISK-ID IS APPLICABLE TO THE REPORTED EVENT. NON-SERIOUS EVENTS ARE MONITORED THROUGH THE TRENDING PROCESS (Q1.5.0001.WI002).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23490690 ↗MalfunctionAug 29, 2025Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam
ACCORDING TO THE EVENT DESCRIPTION METAL SHARDS INSIDE THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22922274 ↗MalfunctionAug 29, 2025Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam
ACCORDING TO THE INFORMATION RECEIVED, METAL SHARDS INSIDE. A PROTEIN TEST WAS PERFORMED AND IT SHOWED NEGATIVE, CONFIRMING IT'S COMING FROM THE GEAR WHEEL INSIDE. ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS NO PATIENT INVOLVED. AND THE ISSUE OCCURRED NOT DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22922264 ↗MalfunctionAug 20, 2025Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam
IT WAS REPORTED THAT THE CHEST SUPPORT ROD WAS MOUNTED THE WRONG WAY AROUND. WHEN ONE TURNS THE WHEEL TO ADJUST THE POSITIONING, METAL SHAVINGS DROP OFF AND ARE LODGED IN THE WHEEL'S MECHANISM. THERE WAS NO HARM TO THE PATIENT OR USER. A DIFFERENT ARTICLE WAS USED TO COMPLETE THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. DUE TO AN INTERNAL REVIEW A SENTINEL CASE WAS FOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22853934 ↗MalfunctionAug 18, 2025Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam
IT WAS REPORTED THAT THE DEVICE IS TOO HARD TO RECLINE NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22834960 ↗MalfunctionAug 5, 2025Mechanical Jam; Damaged Thread; Mechanical Jam; Damaged Thread
IT WAS REPORTED THAT METAL SHAVINGS FELL OUT DURING SURGERY". THE SHAVINGS WERE COMING OUT OF THE METAL WHEEL OF THE ROD AND WERE OUTSIDE OF THE SURGICAL FIELD. ALL OF THE CHIPS (SHAVINGS) COULD BE RECOVERED IN ALL THREE CASES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SURGICAL DELAY OR PROLONGATION AND NO MEDICAL/ SURGICAL/ DIAGNOSTICAL INTERVENTION REQUIRED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22722171 ↗MalfunctionAug 5, 2025Mechanical Jam; Damaged Thread; Mechanical Jam; Damaged Thread
IT WAS REPORTED THAT METAL SHAVINGS FELL OUT DURING SURGERY". THE SHAVINGS WERE COMING OUT OF THE METAL WHEEL OF THE ROD AND WERE OUTSIDE OF THE SURGICAL FIELD. ALL OF THE CHIPS (SHAVINGS) COULD BE RECOVERED IN ALL THREE CASES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SURGICAL DELAY OR PROLONGATION AND NO MEDICAL/ SURGICAL/ DIAGNOSTICAL INTERVENTION REQUIRED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22722108 ↗MalfunctionAug 5, 2025Mechanical Problem; Mechanical Jam; Damaged Thread; Mechanical Problem; Mechanical Jam; Damaged Thread
IT WAS REPORTED THAT METAL SHAVINGS FELL OUT DURING SURGERY". THE SHAVINGS WERE COMING OUT OF THE METAL WHEEL OF THE ROD AND WERE OUTSIDE OF THE SURGICAL FIELD. ALL OF THE CHIPS (SHAVINGS) COULD BE RECOVERED IN ALL THREE CASES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SURGICAL DELAY OR PROLONGATION AND NO MEDICAL/ SURGICAL/ DIAGNOSTICAL INTERVENTION REQUIRED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22722080 ↗MalfunctionAug 4, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE DEVICE HAD BEEN WEARING OUT WITH SOME METAL POWDER ON IT, AND THE DEFECT WAS NOTED AFTER REPROCESSING PROCEDURE AND NOT INVOLVING MEDICAL PROCEDURE" THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22709115 ↗MalfunctionAug 1, 2025Mechanical Jam; Mechanical Jam
ACCORDING TO THE EVENT DESCRIPTION "NO DEFECT DESCRIPTION" THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. CROSS REFERENCE MDR: 9610617-2025-01329. 9610617-2025-01340.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22691218 ↗MalfunctionAug 1, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "IT'S ALREADY BEEN WEARING OUT WITH SOME METAL POWDER ON IT, AND THE DEFECT WAS NOTED AFTER REPROCESSING PROCEDURE AND NOT INVOLVING MEDICAL PROCEDURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22691180 ↗MalfunctionAug 1, 2025Mechanical Jam; Mechanical Jam
ACCORDING TO THE EVENT DESCRIPTION "NO DEFECT DESCRIPTION" THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. CROSS REFERENCE MDR: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22691146 ↗
Other LARYNGOSCOPE, RIGID devices
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls202 reports
- McGRATH MAC 300-000-000Covidien LP · LARYNGOSCOPE, RIGID1 recall1 death205 reports
- n.a. 8404HXKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID242 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID2 deaths192 reports
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls90 reports
- n.a. 8404BXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID141 reports
- n/a 8404AXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID108 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID84 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.
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