Device manufacturer, as written on reports

Gyrus Acmi: medical device reports filed with FDA

7,583 reports name it as the manufacturer of the device involved, 2004–2026.

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.

7,583
reports naming it as manufacturer: 0% of all MAUDE reports; 1,521
reports, 12 months to August 2026: 1,496 in the 12 months before; 82.9%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

7,583 medical device reports received by FDA give Gyrus Acmi as the manufacturer of the device involved, 0% of the MAUDE database, from August 2004 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,521 reports arrived in the 12 months to August 2026, close to the 1,496 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 (82.9%), injury (15.5%) and other (1.1%). 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
SOLTIVE Premium SuperPulsed Laser System	Powered laser surgical instrument	519	117	0%
Shockpulse Lithotripsy Transducer	Lithotriptor, ultrasonic	461	169	0%
THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S	Electrosurgical, cutting & coagulation & accessories	458	403	0%
Single Use Aspiration Needle	Bronchoscope accessory	448	144	0.4%
Powerseal 5mm 37cm Curved Jaw Sealer & Divider Double-Action	Electrosurgical, cutting & coagulation & accessories	420	133	0%
Gyrus Pk-Sp Generator	Electrosurgical, cutting & coagulation & accessories	300	24	0%
Shockpulse-Se Lithotripsy System	Lithotriptor, ultrasonic	268	89	0%
200 Micron Tfl Single Use Fiber	Powered laser surgical instrument	241	33	0%
200 Micron Tfl Ball Tip Single Use Fiber	Powered laser surgical instrument	210	44	0%
Shockpulse-Se Lithotripsy System Reusab	Lithotriptor, ultrasonic	201	73	0%
Powerseal 5mm 23cm Curved Jaw Sealer & Divider Double-Action	Electrosurgical, cutting & coagulation & accessories	150	50	0%
Single Use Aspiration Needle NA-U401SX	Biopsy needle	130	195	0.2%
Pk Cutting Forceps 5mm 33cm	Electrosurgical, cutting & coagulation & accessories	109	1	0%
Olympus	Colonoscope and accessories, flexible/rigid	1	9	2.5%

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
GEI	Electrosurgical, cutting & coagulation & accessories	2,332	30.8%
GEX	Powered laser surgical instrument	1,399	18.4%
FEO	Lithotriptor, ultrasonic	1,064	14%
KTI	Bronchoscope accessory	546	7.2%
HIH	Hysteroscope (and accessories)	272	3.6%
NJK	Valve, pulmonary	248	3.3%
KNQ	Dilator, esophageal	141	1.9%
FCG	Biopsy needle	131	1.7%
FAS	Electrode, electrosurgical, active, urological	113	1.5%
FGB	Ureteroscope and accessories, flexible/rigid	75	1%

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

Death0.2%18

Injury15.5%1,175

Malfunction82.9%6,283

Other1.1%85

Not given0.3%22

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

Questions about Gyrus Acmi reports

How many FDA device reports name Gyrus Acmi as manufacturer?

7,583 reports through August 2026, 1,521 of them in the latest 12 months.

Which of its brands appear most often?

SOLTIVE Premium SuperPulsed Laser System (519), Shockpulse Lithotripsy Transducer (461), THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (458), Single Use Aspiration Needle (448) and Powerseal 5mm 37cm Curved Jaw Sealer & Divider Double-Action (420).

Which device types does it report on?

electrosurgical, cutting & coagulation & accessories (30.8%), powered laser surgical instrument (18.4%), lithotriptor, ultrasonic (14%) and bronchoscope accessory (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.