Device manufacturer, as written on reports

Ponce - Uss: medical device reports filed with FDA

4,253 reports name it as the manufacturer of the device involved, 2001–2010.

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.

4,253
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 45.8%
classified as malfunction: 62.3% across all reports; 1.6%
classified as death, as reported: 0.9% across all reports

4,253 medical device reports received by FDA give Ponce - Uss as the manufacturer of the device involved, 0% of the MAUDE database, from February 2001 to February 2010. 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 injury (49.3%), malfunction (45.8%) and other (3.2%). 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	Classified as death
Premium Plus Ceea 31 Instr W/Tilt-Top	Stapler, surgical	291	1.1%
Spacemaker Blunt Tip Trocar 10mm	Laparoscope, general & plastic surgery	287	0%
Protack 5mm Instrument	Staple, implantable	179	1.6%
Premium Plus Ceea 28 Instr W/Tilt-Top	Stapler, surgical	158	1.3%
Spacemaker Blunt Tip Trocar 12mm	Laparoscope, general & plastic surgery	151	0%
Premium Surgiclip S-9 0 Titanium	Clip, implantable	122	0%
Spacemaker Preperitoneal Dist Balloon	Laparoscope, general & plastic surgery	109	0%
Spacemaker Structural Balloon Trocar	Laparoscope, general & plastic surgery	107	0%
Pediport 5 5mm Short Secondary Port	Laparoscope, general & plastic surgery	105	0%
5 5mm Short Secondary Port	Laparoscope, general & plastic surgery	66	0%
Roticulator Endo Grasp 5mm W/Spin Lock	Motor, surgical instrument, pneumatic powered	57	0%
Gia 80-3 8 Single Use Reloadable Stapler	Staple, implantable	36	2%
Endo Catch Gold 10mm Specimen Pouch Intl	Laryngoscope, endoscope	22	0%
Auto Suture Premium Plus Ceea 28mm	Stapler, surgical	3	0%
Auto Suture Premium Plus Ceea 31mm	Stapler, surgical	3	0.3%
Endo Gia Universal 12mm Single Use Inst	Staple, implantable	3	1.8%
Auto Suture Roticulator 55-4 8	Stapler, surgical	1	0.2%

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
GCJ	Laparoscope, general & plastic surgery	1,624	38.2%
GAG	Stapler, surgical	1,397	32.8%
GDW	Staple, implantable	570	13.4%
DRC	Trocar	339	8%
GDO	Applier, surgical, clip	65	1.5%
GAS	Suture, nonabsorbable, synthetic, polyester	37	0.9%
GDI	Dissector, surgical, general & plastic surgery	30	0.7%
GDT	Staple, removable (skin)	26	0.6%
GAW	Suture, nonabsorbable, synthetic, polypropylene	20	0.5%
GAD	Retractor	11	0.3%

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

Death1.6%66

Injury49.3%2,097

Malfunction45.8%1,950

Other3.2%135

Not given0.1%5

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

Questions about Ponce - Uss reports

How many FDA device reports name Ponce - Uss as manufacturer?

4,253 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Premium Plus Ceea 31 Instr W/Tilt-Top (291), Spacemaker Blunt Tip Trocar 10mm (287), Protack 5mm Instrument (179), Premium Plus Ceea 28 Instr W/Tilt-Top (158) and Spacemaker Blunt Tip Trocar 12mm (151).

Which device types does it report on?

laparoscope, general & plastic surgery (38.2%), stapler, surgical (32.8%), staple, implantable (13.4%) and trocar (8%).

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.