Devices › Applier, surgical, clip
Device brand name · Applier surgical clip
Hol Ml 5mm Endo Applier: medical device reports filed with FDA
457 reports name it, 2014–2025. Manufacturer given most often on reports: Teleflex Medical. Product code GDO.
- 457
- device reports naming the brand
- 0% of all MAUDE reports · about 37 a year
- 0
- reports, 12 months to August 2026
- 15 in the 12 months before
- 99.3%
- classified as malfunction
- 91.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 457 reports that name the brand "Hol Ml 5mm Endo Applier" (applier surgical clip), received between March 2014 and July 2025; the manufacturer given most often on reports is Teleflex Medical. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, against 15 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 (99.3%) and injury (0.7%); across all applier, surgical, clip reports (product code GDO) death is recorded in 0.2% and malfunction in 91.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to align (48.6%), break (12.5%) and material twisted/bent (8.5%). The patient problems coded most often are foreign body in patient, hemorrhage/blood loss/bleeding and perforation of vessels. 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 16,592 reports carrying product code GDO. 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 |
|---|---|---|---|
| Failure to align | 222 | 48.6% | 3.7% |
| Breakthe device broke | 57 | 12.5% | 5% |
| Material twisted/bent | 39 | 8.5% | 0.6% |
| Difficult to open or close | 32 | 7% | 2.3% |
| Activation, positioning or separation problem | 24 | 5.3% | 0.8% |
| Detachment of device or device componentpart of the device came off | 19 | 4.2% | 1.2% |
| Loose or intermittent connection | 11 | 2.4% | 0.3% |
| Separation failure | 10 | 2.2% | 0.3% |
| Positioning failure | 8 | 1.8% | 1.3% |
| Premature activation | 7 | 1.5% | 0.6% |
| Material separation | 6 | 1.3% | 1.3% |
| Entrapment of device | 5 | 1.1% | 0.3% |
| Difficult to position | 4 | 0.9% | 0.2% |
| Mechanical jam | 4 | 0.9% | 1.4% |
| Activation problem | 3 | 0.7% | 0% |
| Material deformation | 3 | 0.7% | 1.6% |
| Material integrity problema problem with the device material | 3 | 0.7% | 0.2% |
| Mechanics altered | 3 | 0.7% | 3.1% |
| Unintended ejection | 3 | 0.7% | 0.5% |
| Insufficient device problem information | 2 | 0.4% | 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 | 1 | 0.2% |
| Hemorrhage/blood loss/bleeding | 1 | 0.2% |
| Perforation of vessels | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Hol Ml 5mm Endo Applier | Product code GDO | All MAUDE reports |
|---|---|---|---|
| Reports | 457 | 16,592 | 26,136,888 |
| Share of that pool | — | 2.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 0.7% | 6.5% | 36.2% |
| Classified as malfunction | 99.3% | 91.5% | 62.3% |
| Filed by the manufacturer | 100% | 93.3% | 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 GDO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ligaclip Endoscopic Rotating Multiple Clip Applier | 4,351 | 0 | 0.1% |
| Ligaclip Multiple Clip Applier | 1,069 | 0 | 0.2% |
| Weck Hol Ml 5mm Endo Applier | 578 | 306 | 0% |
| Ligaclip Mca Small Applier | 557 | 19 | 0.2% |
| Ligaclip Endoscopic Multiple Clip Applier | 560 | 0 | 0% |
| Ligaclip Endoscopic Rotating Multiple Clip Applier 20 | 821 | 0 | 0% |
| Ligaclip Mca Med Applier | 513 | 4 | 0.4% |
| Ligaclip Rotating Multiple Clip Applier | 463 | 0 | 0% |
| Ligaclip Endo Rotating Mca | 2,209 | 109 | 0% |
| Ligaclip Mca Med Long Applier | 408 | 9 | 0.2% |
| Ligaclip Clip Applier | 1,787 | 0 | 0% |
| Ligaclip | 1,425 | 308 | 0% |
| Resolution Clip Device | 1,596 | 0 | 0.3% |
| Ligaclip Mca Large Applier | 268 | 3 | 0.4% |
| Ligaclip 20/20 Multiple Clip Applier | 250 | 0 | 0% |
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 Hol Ml 5mm Endo Applier reports
How many FDA reports name Hol Ml 5mm Endo Applier?
457 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?
malfunction (99.3%) and injury (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to align (48.6%), break (12.5%), material twisted/bent (8.5%), difficult to open or close (7%) and activation, positioning or separation problem (5.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Hol Ml 5mm Endo Applier 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.