General surgery tray: medical device reports filed with FDA

21,411 reports carry this product code, 1996–2026; 13 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.

21,411
reports with this product code: 0.1% of all MAUDE reports; 7,542
reports, 12 months to August 2026: 4,069 in the 12 months before; 92.1%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code LRO is FDA's classification for "General surgery tray" (general, Plastic Surgery panel), a class 2 device. 21,411 medical device reports carry this product code, 0.1% of the MAUDE database, from January 1996 to August 2026.

7,542 reports arrived in the 12 months to August 2026, up 85% from 4,069 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 (92.1%), injury (7.2%) and other (0.6%). 13 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
CONSTELLATION Surgical Procedure Pack	10,652	5,185	0%	98.1%
CONSTELLATION Surgical Procedure Pak	3,177	134	0%	94.7%
CENTURION Surgical Procedure Pak	3,018	929	0%	89.2%
CUSTOM-PAK Surgical Procedure Pack	648	34	0%	59.2%
Infiniti Surgical Procedure Pak	223	1	0%	83.9%
UNITY TOTAL PLUS Combined Procedure Pack	212	199	0%	90.6%
CENTURION ULTRAVIT Probe Procedure Pak	180	52	0%	95%
Deroyal	144	14	0.7%	72.7%
Medline Industries, Inc.	74	100	0.2%	74.1%
Cardinal Health	58	185	0.2%	89.8%
Custom Pak	37	0	0%	74.1%
Halyard	7	11	1.3%	94.9%
CONSTELLATION ULTRAVIT Probe	4	196	0%	98.8%

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
Alcon Research - Houston	18,598	86.9%
Medline Industries	995	4.6%
Deroyal Industries	334	1.6%
Cardinal Health 200	196	0.9%
Pt Ciba Vision Batam	179	0.8%
Cardinal Health	82	0.4%
Allegiance Healthcare	37	0.2%
Alcon Research - Irvine Technology Center	18	0.1%
Alcon Laboratories	11	0.1%
Merit Medical Systems	7	0%
Alcon - Irvine Technology Center	2	0%
Angiodynamics	2	0%
Bard Access Systems	2	0%
Ethicon Endo Surgery Cincinnati	2	0%
3m Health Care	1	0%

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

Death0%2

Injury7.2%1,543

Malfunction92.1%19,718

Other0.6%122

Not given0.1%26

Who filed

Manufacturer report95.8%20,502

Voluntary report1.4%300

User facility report0%0

Distributor report0%1

Not given2.8%608

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

Device problems coded

Device problem (FDA code)	Reports	Share
Failure to cut	7,691	35.9%
Suction problem	2,652	12.4%
Leak/splashthe device leaked	1,754	8.2%
Suction failure	1,489	7%
Breakthe device broke	968	4.5%
Fluid/blood leak	871	4.1%
Obstruction of flow	551	2.6%
Material twisted/bent	499	2.3%
Infusion or flow problema problem with flow or infusion	370	1.7%
Ambient noise problem	366	1.7%
Inability to irrigate	332	1.6%
Air/gas in device	311	1.5%
Complete blockage	301	1.4%
Dull, blunt	299	1.4%
Contamination /decontamination problem	243	1.1%
Incomplete or inadequate connection	226	1.1%
Device contamination with chemical or other material	220	1%
Detachment of device or device componentpart of the device came off	210	1%
Contamination	201	0.9%
Improper flow or infusion	185	0.9%

Questions about general surgery tray reports

What is product code LRO?

FDA's classification code for "General surgery tray", class 2, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

21,411 reports through August 2026, 7,542 of them in the latest 12 months.

Which brands appear most often?

CONSTELLATION Surgical Procedure Pack (10,652), CONSTELLATION Surgical Procedure Pak (3,177), CENTURION Surgical Procedure Pak (3,018), CUSTOM-PAK Surgical Procedure Pack (648) and Infiniti Surgical Procedure Pak (223). 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.