Devices › Electrode, electrosurgical, active, urological
Device brand name · Electrode bipolar
Electrode, bipolar: medical device reports filed with FDA
203 reports name it, 2023–2026. Manufacturer given most often on reports: Karl Storz Se & Kg. Product code FAS.
- 203
- device reports naming the brand
- 0% of all MAUDE reports · about 58 a year
- 104
- reports, 12 months to August 2026
- 52 in the 12 months before
- 53.7%
- classified as malfunction
- 78.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
203 medical device reports received by FDA name the brand "Electrode, bipolar" (electrode bipolar); the manufacturer given most often on reports is Karl Storz Se & Kg; received from January 2023 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
104 reports arrived in the 12 months to August 2026, up 100% from 52 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 malfunction (53.7%) and injury (46.3%); across all electrode, electrosurgical, active, urological reports (product code FAS) death is recorded in 0.2% and malfunction in 78.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (54.7%), detachment of device or device component (24.1%) and material fragmentation (8.4%). The patient problems coded most often are foreign body in patient, electric shock and laceration(s). 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,390 reports carrying product code FAS. 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 |
|---|---|---|---|
| Breakthe device broke | 111 | 54.7% | 49.4% |
| Detachment of device or device componentpart of the device came off | 49 | 24.1% | 10.6% |
| Material fragmentation | 17 | 8.4% | 6.8% |
| Insufficient device problem information | 9 | 4.4% | 1.3% |
| Arcing | 7 | 3.4% | 1.2% |
| Explosion | 5 | 2.5% | 0.3% |
| Material separation | 5 | 2.5% | 2.3% |
| Mechanical problema mechanical problem | 4 | 2% | 4.7% |
| Melted | 4 | 2% | 4.1% |
| Sparking | 4 | 2% | 5.1% |
| Arcing of electrodes | 3 | 1.5% | 0.8% |
| Unintended electrical shock | 3 | 1.5% | 0.4% |
| Crackthe device cracked | 2 | 1% | 1% |
| Electrical /electronic property probleman electrical or electronic problem | 2 | 1% | 0.8% |
| Component missing | 1 | 0.5% | 0.6% |
| Device damaged by another device | 1 | 0.5% | 0.1% |
| Device dislodged or dislocated | 1 | 0.5% | 0% |
| Energy output problem | 1 | 0.5% | 0.3% |
| Excessive heating | 1 | 0.5% | 0.7% |
| Flare or flash | 1 | 0.5% | 0.3% |
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 in patientpart of a device left in the patient | 28 | 13.8% |
| Electric shockan electric shock | 2 | 1% |
| Laceration(s) | 2 | 1% |
| Abdominal painstomach or belly pain | 1 | 0.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.5% |
| Bone cement implantation syndrome | 1 | 0.5% |
| Uterine perforationa hole in the wall of the womb | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Electrode, bipolar | Product code FAS | All MAUDE reports |
|---|---|---|---|
| Reports | 203 | 2,390 | 26,136,888 |
| Share of that pool | — | 8.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 46.3% | 19.4% | 36.2% |
| Classified as malfunction | 53.7% | 78.7% | 62.3% |
| Filed by the manufacturer | 77.3% | 86.4% | 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 FAS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| HF-resection electrode, loop, 24 Fr., 0.2 wire, medium, 12 | 228 | 101 | 0% |
| Olympus | 2,240 | 9 | 2.5% |
| Inner sheath, for 26 Fr. outer sheath | 2,002 | 533 | 0% |
| Karl Storz | 633 | 0 | 2.1% |
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 Electrode, bipolar reports
How many FDA reports name Electrode, bipolar?
203 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 104 in the latest 12 months.
What kinds of events are reported?
malfunction (53.7%) and injury (46.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (54.7%), detachment of device or device component (24.1%), material fragmentation (8.4%), insufficient device problem information (4.4%) and arcing (3.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (77.3%), distributor reports (21.2%) and voluntary reports (1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Electrode, bipolar 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.