Device manufacturer, as written on reports

Ethicon Endo-Surgery: medical device reports filed with FDA

170,810 reports name it as the manufacturer of the device involved, 1993–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

170,810
reports naming it as manufacturer: 0.7% of all MAUDE reports; 9,648
reports, 12 months to August 2026: 10,202 in the 12 months before; 89.7%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

170,810 medical device reports received by FDA give Ethicon Endo-Surgery as the manufacturer of the device involved, 0.7% of the MAUDE database, from August 1993 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

9,648 reports arrived in the 12 months to August 2026, close to the 10,202 of 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 (89.7%), injury (9.5%) and death (0.4%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Ultracision Harmonic Ace	Instrument, ultrasonic surgical	8,425	0	0%
Harmonic Ace Plus 7 Adv Hemostasis 36	Instrument, ultrasonic surgical	6,830	537	0%
Ligamax-5mm Endo Clip Applier	Clip, implantable	5,956	234	0%
Harmonic Hd 1000i Shears 36cm Shaft	Instrument, ultrasonic surgical	5,026	196	0%
Powered 60 Echelon + 340mm Shaft	Staple, implantable	3,208	224	0.4%
Harmonic Lap 5mm Shear 36cm	Instrument, ultrasonic surgical	2,690	88	0%
Ligaclip Endoscopic Rotating Multiple Clip Applier	Applier, surgical, clip	2,544	0	0.1%
Ets Flex Articng Lnr Cutr 45mm	Staple, implantable	2,379	79	0.3%
Harmonic Ace 36cm W Erg Handle	Instrument, ultrasonic surgical	2,288	0	0%
Rotating Multiple Clip Applier	Clip, implantable	1,790	0	0.2%
Ils 29mm Curved	Staple, implantable	1,787	48	0.9%
Ligaclip Endo Rotating Mca	Clip, implantable	1,767	109	0%
Echelon Flex Powered Vascular Stapler With Advanced Placement Tip	Staple, implantable	1,753	180	1.6%
Powered 60 Echelon + 440mm Shaft	Staple, implantable	1,730	49	0.4%
Ligaclip Clip Applier	Clip, implantable	1,719	0	0%
Endopath Ets	—	1,544	0	0.2%
Contour Curved Cutter Stapler	Staple, implantable	1,533	11	0.3%
75mm Selectable New Tlc	Staple, implantable	1,507	57	1.1%
Pwrd 29mm Curved Circular 18cm Shaft	Staple, implantable	1,470	91	0.4%
Flex 60 Articulating	Staple, implantable	1,457	79	0.7%
Harmonic Scalpel Ultracision Hand Piece	Instrument, ultrasonic surgical	1,424	0	0.1%
Echelon Linear Cutter	Staple, implantable	1,403	69	0.6%
Harmonic 1100 Shears 36cm	Instrument, ultrasonic surgical	1,402	203	0.1%
Endopath Endoscopic Multifeed Stapler	Stapler, surgical	1,276	0	0%
Harmonic ACE	Instrument, ultrasonic surgical	1,242	680	0.1%
Ligaclip	Clip, implantable	1,242	308	0%
Ligaclip Endoscopic Clip Applier	Clip, implantable	1,239	0	0%
Endopath Dilating Tip Trocar	Laparoscope, general & plastic surgery	1,215	0	0.4%
Powered Plus Standard 45	Staple, implantable	1,215	87	0.3%
Ligamax-5mm	Clip, implantable	1,209	0	0.1%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
GDW	Staple, implantable	65,613	38.4%
LFL	Instrument, ultrasonic surgical	45,501	26.6%
FZP	Clip, implantable	20,662	12.1%
GCJ	Laparoscope, general & plastic surgery	12,341	7.2%
GDO	Applier, surgical, clip	6,314	3.7%
GAG	Stapler, surgical	6,299	3.7%
GEI	Electrosurgical, cutting & coagulation & accessories	6,275	3.7%
GDT	Staple, removable (skin)	1,272	0.7%
KNW	Instrument, biopsy	514	0.3%
OXC	Mesh, surgical, absorbable, staple line reinforcement	327	0.2%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.4%715

Injury9.5%16,276

Malfunction89.7%153,192

Other0.1%92

Not given0.3%535

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Ethicon Endo-Surgery reports

How many FDA device reports name Ethicon Endo-Surgery as manufacturer?

170,810 reports through August 2026, 9,648 of them in the latest 12 months.

Which of its brands appear most often?

Ultracision Harmonic Ace (8,425), Harmonic Ace Plus 7 Adv Hemostasis 36 (6,830), Ligamax-5mm Endo Clip Applier (5,956), Harmonic Hd 1000i Shears 36cm Shaft (5,026) and Powered 60 Echelon + 340mm Shaft (3,208).

Which device types does it report on?

staple, implantable (38.4%), instrument, ultrasonic surgical (26.6%), clip, implantable (12.1%) and laparoscope, general & plastic surgery (7.2%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.