Device manufacturer, as written on reports

Davis & Geck Caribe: medical device reports filed with FDA

22,230 reports name it as the manufacturer of the device involved, 2017–2026.

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.

22,230
reports naming it as manufacturer: 0.1% of all MAUDE reports; 2,901
reports, 12 months to August 2026: 2,438 in the 12 months before; 88.9%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

22,230 medical device reports received by FDA give Davis & Geck Caribe as the manufacturer of the device involved, 0.1% of the MAUDE database, from February 2017 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

2,901 reports arrived in the 12 months to August 2026, up 19% from 2,438 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 (88.9%), injury (10.9%) and death (0.2%). 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
Polysorb	Suture, absorbable, synthetic, polyglycolic acid	2,194	1,836	0%
VersaOne	Laparoscope, general & plastic surgery	1,828	251	0.2%
Maxon	Suture, absorbable, synthetic, polyglycolic acid	1,770	309	0%
Biosyn	Suture, absorbable, synthetic, polyglycolic acid	1,642	261	0%
Endo Stitch	Endoscopic tissue approximation device	1,537	64	0.1%
Versaport	Laparoscope, general & plastic surgery	1,143	64	0.1%
Endo Clip	Clip, implantable	986	85	0.1%
Endo Catch Gold	Laryngoscope, endoscope	729	83	0%
Surgipro ll	Suture, nonabsorbable, synthetic, polypropylene	515	37	0.5%
Caprosyn	Suture, absorbable, synthetic, polyglycolic acid	387	94	0%
Monosof	Suture, nonabsorbable, synthetic, polyamide	358	89	0%
Sofsilk	Suture, nonabsorbable, silk	354	49	0%
Surgipro	Mesh, surgical, polymeric	279	89	0.9%
Ti-Cron	Suture, nonabsorbable, synthetic, polyethylene	234	28	0.4%
Surgidac	Endoscopic tissue approximation device	232	4	0%
Unknown Endo Stitch SULU	Staple, implantable	224	17	0%
Auto Suture	Laparoscope, general & plastic surgery	171	234	0.1%
Versaport Plus	Laparoscope, general & plastic surgery	162	5	1%
Steel	Suture, nonabsorbable, steel, monofilament and multifilament, sterile	148	7	0%
McKesson	Syringe, piston	138	74	0%
Versastep	Laparoscope, general & plastic surgery	138	0	0%
Versastep Plus	Laparoscope, general & plastic surgery	129	12	0%
Appose Ulc	Staple, removable (skin)	120	27	0%
Unknown Polysorb Suture	Suture, absorbable, synthetic, polyglycolic acid	112	10	0.6%
Unknown Suture Product	Suture, absorbable, synthetic, polyglycolic acid	45	28	0.9%
Endo GIA	Staple, implantable	11	2,086	0.3%
V-Loc 180	Suture, absorbable, synthetic, polyglycolic acid	9	678	0%
Hugo RAS System	Modular electromechanical surgical system	8	1,428	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
GAM	Suture, absorbable, synthetic, polyglycolic acid	6,401	28.8%
FZP	Clip, implantable	4,333	19.5%
GCJ	Laparoscope, general & plastic surgery	3,901	17.5%
OCW	Endoscopic tissue approximation device	1,759	7.9%
GAW	Suture, nonabsorbable, synthetic, polypropylene	1,660	7.5%
GCI	Laryngoscope, endoscope	977	4.4%
GAR	Suture, nonabsorbable, synthetic, polyamide	556	2.5%
GAT	Suture, nonabsorbable, synthetic, polyethylene	425	1.9%
GDW	Staple, implantable	342	1.5%
GDO	Applier, surgical, clip	214	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%34

Injury10.9%2,430

Malfunction88.9%19,764

Other0%2

Not given0%0

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

Questions about Davis & Geck Caribe reports

How many FDA device reports name Davis & Geck Caribe as manufacturer?

22,230 reports through August 2026, 2,901 of them in the latest 12 months.

Which of its brands appear most often?

Polysorb (2,194), VersaOne (1,828), Maxon (1,770), Biosyn (1,642) and Endo Stitch (1,537).

Which device types does it report on?

suture, absorbable, synthetic, polyglycolic acid (28.8%), clip, implantable (19.5%), laparoscope, general & plastic surgery (17.5%) and endoscopic tissue approximation device (7.9%).

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.