Apparatus, suction, operating-room, wall vacuum powered: medical device reports filed with FDA

1,757 reports carry this product code, 1992–2026; 4 brands with a page.

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.

1,757
reports with this product code: 0% of all MAUDE reports; 155
reports, 12 months to August 2026: 250 in the 12 months before; 90.8%
classified as malfunction: 62.3% across all reports; 1.2%
classified as death, as reported: 0.9% across all reports

Product code GCX is FDA's classification for "Apparatus, suction, operating-room, wall vacuum powered" (general Hospital panel), a class 2 device. 1,757 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

155 reports arrived in the 12 months to August 2026, down 38% from 250 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 (90.8%), injury (5.9%) and death (1.2%). 4 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Pkg Assy Strykeflow 2 With Tip	237	63	0%	98.7%
Argyle	17	60	1%	82.4%
Cws 400 Closed Wound Suction Kit Pvc Drain	1	0	0%	88.6%
J-VAC Reservoir	1	16	0.4%	86.1%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Stryker Endoscopy-San Jose	403	22.9%
Stryker Endoscopy	106	6%
Stryker Endoscopy Puerto Rico	102	5.8%
Hospira	87	5%
Cardinal Health	58	3.3%
Stryker	41	2.3%
Cardinal Health 200	34	1.9%
Abbott Laboratories	20	1.1%
Stryker Instruments	16	0.9%
Conmed	12	0.7%
Consolidated Medical Equipment	12	0.7%
Baxter Healthcare	4	0.2%
Gyrus Acmi	3	0.2%
C R Bard	1	0.1%
Medline Industries	1	0.1%

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 and report source

Event type

Death1.2%21

Injury5.9%104

Malfunction90.8%1,595

Other1%18

Not given1.1%19

Who filed

Manufacturer report82%1,440

Voluntary report5.6%99

User facility report0%0

Distributor report0.5%8

Not given12%210

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Suction problem	342	19.5%
Device contamination with chemical or other material	132	7.5%
Fluid/blood leak	115	6.5%
Leak/splashthe device leaked	85	4.8%
Breakthe device broke	77	4.4%
Decrease in pressure	73	4.2%
Smoking	72	4.1%
Delivered as unsterile product	71	4%
Device contaminated during manufacture or shipping	64	3.6%
Replace	58	3.3%
Vacuum, loss of	52	3%
Crackthe device cracked	51	2.9%
Overheating of device	42	2.4%
Suction failure	42	2.4%
Sticking	41	2.3%
Detachment of device or device componentpart of the device came off	39	2.2%
Temperature problem	38	2.2%
Packaging problem	32	1.8%
Mechanical problema mechanical problem	31	1.8%
Detachment of device component	29	1.7%

Questions about apparatus, suction, operating-room, wall vacuum powered reports

What is product code GCX?

FDA's classification code for "Apparatus, suction, operating-room, wall vacuum powered", class 2, reviewed by the general Hospital panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,757 reports through August 2026, 155 of them in the latest 12 months.

Which brands appear most often?

Pkg Assy Strykeflow 2 With Tip (237), Argyle (17), Cws 400 Closed Wound Suction Kit Pvc Drain (1) and J-VAC Reservoir (1). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. 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 differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.