Device manufacturer, as written on reports

Stryker Endoscopy-San Jose: medical device reports filed with FDA

13,026 reports name it as the manufacturer of the device involved, 2013–2026.

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.

13,026
reports naming it as manufacturer: 0.1% of all MAUDE reports; 1,085
reports, 12 months to August 2026: 1,144 in the 12 months before; 90%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

13,026 medical device reports received by FDA give Stryker Endoscopy-San Jose as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 2013 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,085 reports arrived in the 12 months to August 2026, close to the 1,144 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 (90%), injury (9.9%) and death (0.1%). 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
5mm 33cm Peek Monopolar Handle 33cm	—	755	0	0%
Serfas Energy 90-S Cruise	Electrosurgical, cutting & coagulation & accessories	412	24	0%
Pkg 5mm Peek Monopolar Handle	Endoscopic grasping/cutting instrument, non-powered	406	0	0%
5mm Peek Multifunction Handle	—	348	0	0%
PKG 1688 Camera Control Unit CCU	Laparoscope, general & plastic surgery	312	49	0%
Pkg Crossfire 2 Console	Electrosurgical, cutting & coagulation & accessories	299	31	0%
5mm Monopolar Handle 33cm	—	252	0	0%
PKG L11 LED Light Source with AIM	Confocal optical imaging	246	31	0%
Unknown_Endoscopy_Product	Electrosurgical, cutting & coagulation & accessories	238	22	0.4%
Pkg Assy Strykeflow 2 With Tip	Apparatus, suction, operating-room, wall vacuum powered	235	63	0%
5mm Ratcheted Handle 33cm	Endoscopic grasping/cutting instrument, non-powered	197	0	0%
Pkg Assy Suction Irrigator 2	Laparoscope, general & plastic surgery	183	23	0%
10mm 33cm Peek Monopolar Handle	—	171	0	0%
3 5mm 90-S Serfas Energy Suction Probe	Electrosurgical, cutting & coagulation & accessories	167	0	0%
Pkg Connected Or Hub Base System	Laparoscope, general & plastic surgery	153	61	0.6%
4 0mm 90-S Max Serfas Energy Suction Probe	Electrosurgical, cutting & coagulation & accessories	130	0	0%
4 0mm Aggressive Plus Cutter Formula 5bx	Arthroscope	58	0	0%
Serfas Energy Super 90-S	Electrosurgical, cutting & coagulation & accessories	54	0	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
GCJ	Laparoscope, general & plastic surgery	2,157	16.6%
OCZ	Endoscopic grasping/cutting instrument, non-powered	1,966	15.1%
GEI	Electrosurgical, cutting & coagulation & accessories	1,962	15.1%
HRX	Arthroscope	876	6.7%
MBI	Fastener, fixation, nondegradable, soft tissue	751	5.8%
OWN	Confocal optical imaging	659	5.1%
GFA	Blade, saw, general & plastic surgery, surgical	586	4.5%
GCX	Apparatus, suction, operating-room, wall vacuum powered	403	3.1%
NBH	Accessories, arthroscopic	368	2.8%
HIF	Insufflator, laparoscopic	313	2.4%

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

Death0.1%8

Injury9.9%1,295

Malfunction90%11,723

Other0%0

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 Stryker Endoscopy-San Jose reports

How many FDA device reports name Stryker Endoscopy-San Jose as manufacturer?

13,026 reports through August 2026, 1,085 of them in the latest 12 months.

Which of its brands appear most often?

5mm 33cm Peek Monopolar Handle 33cm (755), Serfas Energy 90-S Cruise (412), Pkg 5mm Peek Monopolar Handle (406), 5mm Peek Multifunction Handle (348) and PKG 1688 Camera Control Unit CCU (312).

Which device types does it report on?

laparoscope, general & plastic surgery (16.6%), endoscopic grasping/cutting instrument, non-powered (15.1%), electrosurgical, cutting & coagulation & accessories (15.1%) and arthroscope (6.7%).

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.