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2026 data FDA MAUDE openFDA FDA Class II

System, Applicator, Radionuclide, Remote-Controlled

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §892.5700 (Radiology panel).

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FDA MAUDE casebook

openFDA event book System LIGHT-BOOK · MAUDE

#956 of 1000 · 413 reports · 1995–2026

  • BOOK 413 reports
  • RANK #956 of 1000
  • DEATH 0 death-typed
  • INJ 116 injury-typed
  • MALF 208 malfunction
  • SPAN 1995–2026
  • PEAK 2013: 43
  • PHOTO Burr, Orthopedic

Nearest event-volume peer: Burr, Orthopedic (1 report gap)

System, Applicator, Radionuclide, Remote-Controlled sits #956 of 1000 among tracked device types with 413 MAUDE reports spanning 1995–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports sit below the device-type norm

System carries 50.4% MALFUNCTION-coded reports, 14.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 28.1% corpus 30.3% · below corpus mean (-2.2 pp)
  • MALF 50.4% corpus 64.8% · below corpus mean (-14.5 pp)

Lead product-problem code Break is 8% of coded problems · Lead manufacturer HOLOGIC, INC. accounts for 100% of manufacturer-tagged reports · Top event location is 67% of location-tagged rows .

System in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows System, Applicator, Radionuclide, Remote-Controlled carries 413 MAUDE reports, ranked #956 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 208 (50.4%)
Injury 116 (28.1%)
Other 71 (17.2%)
18 (4.4%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Other 164 (37.1%)
147 (33.3%)
Required Intervention 75 (17.0%)
Hospitalization 22 (5.0%)
R 16 (3.6%)
O 9 (2.0%)
Disability 5 (1.1%)
S 3 (0.7%)
L 1 (0.2%)

Top Product Problems

Break 29
Adverse Event Without Identified Device or Use Problem 28
Replace 26
Improper or Incorrect Procedure or Method 25
Explanted 23
Insufficient Device Problem Information 22
Device, removal of (non-implant) 21
Device Operates Differently Than Expected 19
Retraction Problem 19
Balloon rupture 18
Device Displays Incorrect Message 16
Material Rupture 16
Malposition of Device 13
Computer Software Problem 12
Device Slipped 12
Fluid/Blood Leak 12
Use of Device Problem 12
Material Separation 10
Unknown (for use when the device problem is not known) 10
Defective Component 9

Yearly Trend

95
1995: 2
97
1997: 8
98
1998: 20
99
1999: 11
00
2000: 2
01
2001: 1
02
2002: 4
03
2003: 15
04
2004: 12
05
2005: 16
06
2006: 14
07
2007: 13
08
2008: 32
09
2009: 35
10
2010: 36
11
2011: 42
12
2012: 34
13
2013: 43
14
2014: 18
15
2015: 7
16
2016: 3
17
2017: 5
18
2018: 2
19
2019: 8
20
2020: 8
21
2021: 5
22
2022: 5
23
2023: 3
24
2024: 1
25
2025: 3
26
2026: 5

Reports rose to 3 in 2025, up from an average of 2 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for System, Applicator, Radionuclide, Remote-Controlled

Top Manufacturers

HOLOGIC, INC. 10

Event Locations

276 (66.8%)
HOSPITAL 84 (20.3%)
I 21 (5.1%)
NO INFORMATION 12 (2.9%)
OUTPATIENT TREATMENT FACILITY 8 (1.9%)
UNKNOWN 5 (1.2%)
OTHER 4 (1.0%)
HOME 3 (0.7%)

Nationwide devices with a comparable report-volume footprint

System carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (413 here).

Burr, Orthopedic 414 Pliers, Surgical 412 Manometer, Spinal-Fluid 411 Mass Spectrometry 411

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for System are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for System; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.