Devices › Endoscopic access overtube, gastroenterology-urology
Device brand name · Resectoscope sheath
Karl Storz: medical device reports filed with FDA
633 reports name it, 1994–2014. Manufacturer given most often on reports: Karl Storz & Kg. Product code FED.
- 633
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 24.6%
- classified as malfunction
- 72.1% across the product code
- 2.1%
- classified as death, as reported
- 13 reports · not verified by FDA
633 medical device reports received by FDA name the brand "Karl Storz" (resectoscope sheath); the manufacturer given most often on reports is Karl Storz & Kg; received from May 1994 to October 2014. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are other (51.3%), malfunction (24.6%) and injury (17.4%); across all endoscopic access overtube, gastroenterology-urology reports (product code FED) death is recorded in 1.7% and malfunction in 72.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are tip breakage (21.3%), break (17.9%) and normal (14.1%). The patient problems coded most often are foreign body, removal of, burn(s) and surgical procedure, additional. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Karl Storz was received in the five years to August 2026; the latest was received in October 2014.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,322 reports carrying product code FED. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Tip breakage | 135 | 21.3% | 19.4% |
| Breakthe device broke | 113 | 17.9% | 15.7% |
| Normal | 89 | 14.1% | 0.4% |
| Device, or device fragments remain in patient | 53 | 8.4% | 3.6% |
| Detachment of device component | 51 | 8.1% | 9.7% |
| Difficult to removethe device was hard to remove | 36 | 5.7% | 2.7% |
| Device issuea problem with the device | 31 | 4.9% | 0% |
| Replace | 26 | 4.1% | 2.6% |
| Arcing | 20 | 3.2% | 0.2% |
| Material separation | 16 | 2.5% | 4.1% |
| Component(s), broken | 15 | 2.4% | 2.3% |
| Device, removal of (non-implant) | 15 | 2.4% | 2.2% |
| Other (for use when an appropriate device code cannot be identified) | 11 | 1.7% | 0.8% |
| Thermal decomposition of device | 10 | 1.6% | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 7 | 1.1% | 0.3% |
| Component missing | 6 | 0.9% | 0.5% |
| Fire | 6 | 0.9% | 0% |
| Insufficient device problem information | 6 | 0.9% | 1.3% |
| System fails to activate | 6 | 0.9% | 0% |
| Difficult to insertthe device was hard to insert | 5 | 0.8% | 4.8% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Foreign body, removal of | 124 | 19.6% |
| Burn(s)a burn | 88 | 13.9% |
| Surgical procedure, additional | 67 | 10.6% |
| Nonresorbable materials, unretrieved in body | 65 | 10.3% |
| Therapy/non-surgical treatment, additional | 59 | 9.3% |
| Surgical procedure aborted/stopped | 57 | 9% |
| Surgery, prolonged | 41 | 6.5% |
| Surgical procedure | 30 | 4.7% |
| Perforation | 22 | 3.5% |
| Burn, thermal | 19 | 3% |
| Other (for use when an appropriate patient code cannot be identified) | 16 | 2.5% |
| Bleeding | 15 | 2.4% |
| Internal organ perforation | 12 | 1.9% |
| Deaththe patient died; cause not stated by this term | 11 | 1.7% |
| Hematomaa collection of blood under the skin or in tissue | 11 | 1.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Karl Storz | Product code FED | All MAUDE reports |
|---|---|---|---|
| Reports | 633 | 1,322 | 26,136,888 |
| Share of that pool | — | 47.9% | 0% |
| Classified as death, per 1,000 reports | 21 | 17 | 9 |
| Classified as injury | 17.4% | 18.9% | 36.2% |
| Classified as malfunction | 24.6% | 72.1% | 62.3% |
| Filed by the manufacturer | 43.3% | 84.1% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code FED
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Navigator Hd | 166 | 3 | 0.6% |
| Inner sheath, for 26 Fr. outer sheath | 2,002 | 533 | 0% |
| Resection sheath, 24 Fr. | 759 | 170 | 0.1% |
| Olympus | 2,240 | 9 | 2.5% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Karl Storz reports
How many FDA reports name Karl Storz?
633 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
other (51.3%), malfunction (24.6%) and injury (17.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
tip breakage (21.3%), break (17.9%), normal (14.1%), device, or device fragments remain in patient (8.4%) and detachment of device component (8.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
distributor reports (43.9%), manufacturer reports (43.3%) and voluntary reports (6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Karl Storz was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.