Device manufacturer, as written on reports

Ethicon Endo Surgery: medical device reports filed with FDA

2,183 reports name it as the manufacturer of the device involved, 1994–2022.

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.

2,183
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 85.4%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

2,183 medical device reports received by FDA give Ethicon Endo Surgery as the manufacturer of the device involved, 0% of the MAUDE database, from February 1994 to October 2022. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

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 malfunction (85.4%), injury (12.3%) and other (1%). 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 Surg Dev Curved Shears Endo	Instrument, ultrasonic surgical	90	0	0%
Ligaclip Endoscopic Rotating Multiple Clip Applier 20	Applier, surgical, clip	68	0	0%
Ethicon	Stapler, surgical	61	164	2.3%
Harmonic Ace 36 Cm	Instrument, ultrasonic surgical	59	0	0.1%
Endopath Ets Flex45 Endoscopic Articulating Linear	Laparoscope, general & plastic surgery	56	0	0.5%
Ligamax-5mm Endo Clip Applier	Clip, implantable	56	234	0%
Ultracision Harmonic Ace	Instrument, ultrasonic surgical	42	0	0%
Harmonic Scalpel Hand Piece	Instrument, ultrasonic surgical	39	23	0%
Ligaclip Endo Rotating Mca	Clip, implantable	34	109	0%
Proximate Ils Circular Staplers	Stapler, surgical	30	0	0%
Ultracision Harmonic Scalpel Curved Shears Lcs	Instrument, ultrasonic surgical	29	0	0.2%
Ultracision Surgery Reusable Devices Handpiece 54 55	Instrument, ultrasonic surgical	28	0	0%
Proximate Reloadable Linear Cutter With Safety Lock-Out	Staple, implantable	24	0	1%
Proximate Ils Curved Cir Stapl	Staple, implantable	21	0	0.7%
Ultracision Harmonic Scalpel Hand Piece	Instrument, ultrasonic surgical	21	0	0%
Ultracision Surg Dev Curved Shears Open	Instrument, ultrasonic surgical	21	0	0%
Ultracision Surgical Device Curved Shears Endo	Instrument, ultrasonic surgical	21	0	0%
Lap Disc Hand Access Device	Laparoscope, general & plastic surgery	19	0	0%
Endo Linear Cutters - Ets45mm	—	18	0	0.4%
Ligaclip Endoscopic Rotating Multiple Clip Applier	Applier, surgical, clip	18	0	0.1%
Proximate Pph Procedure Set	Staple, implantable	17	4	0.2%
Harmonic ACE	Instrument, ultrasonic surgical	15	680	0.1%
Harmonic Scalpel Curved Shear	Instrument, ultrasonic surgical	15	0	0%
Proximate Reloadable Linear Stapler	Stapler, surgical	15	0	1.4%
Mtome St Holster/Cables	Instrument, biopsy	14	0	0%
Ligaclip	Clip, implantable	13	308	0%
Echelon 60 Endopath Stapler	Staple, implantable	11	0	0.5%
Hs Hand Controlled Curved Shea	Electrosurgical, cutting & coagulation & accessories	11	0	0.2%
Mammotome Control Module With Smartvac - 120v	Instrument, biopsy	11	0	0%
Proximate Hcs Pph Set	Staple, implantable	11	0	0%

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
LFL	Instrument, ultrasonic surgical	578	26.5%
GCJ	Laparoscope, general & plastic surgery	277	12.7%
GDW	Staple, implantable	266	12.2%
GAG	Stapler, surgical	263	12%
GDO	Applier, surgical, clip	203	9.3%
FZP	Clip, implantable	194	8.9%
GEI	Electrosurgical, cutting & coagulation & accessories	77	3.5%
KNW	Instrument, biopsy	66	3%
KNS	Unit, electrosurgical, endoscopic (with or without accessories)	14	0.6%
LKF	Cannula, manipulator/injector, uterine	8	0.4%

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

Death0.5%11

Injury12.3%269

Malfunction85.4%1,864

Other1%21

Not given0.8%18

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?

2,183 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Ultracision Surg Dev Curved Shears Endo (90), Ligaclip Endoscopic Rotating Multiple Clip Applier 20 (68), Ethicon (61), Harmonic Ace 36 Cm (59) and Endopath Ets Flex45 Endoscopic Articulating Linear (56).

Which device types does it report on?

instrument, ultrasonic surgical (26.5%), laparoscope, general & plastic surgery (12.7%), staple, implantable (12.2%) and stapler, surgical (12%).

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.