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2026 data FDA MAUDE openFDA FDA Class I

Instrument, Ligature Passing And Knot Tying

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4800 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Instrument, Ligature Passing And Knot Tying LIGHT-BOOK · MAUDE

#809 of 1000 · 635 reports · 1995–2026

  • BOOK 635 reports
  • RANK #809 of 1000
  • DEATH 6 death-typed
  • INJ 71 injury-typed
  • MALF 551 malfunction
  • SPAN 1995–2026
  • PEAK 2024: 124
  • PHOTO Polymer Patient Exami…

Nearest event-volume peer: Polymer Patient Examination Glove (0 report gap)

Instrument, Ligature Passing And Knot Tying sits #809 of 1000 among tracked device types with 635 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 run above the device-type norm

Instrument, Ligature Passing And Knot Tying carries 86.8% MALFUNCTION-coded reports, 21.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.9% corpus 1.5% · below corpus mean (-0.6 pp)
  • INJ 11.2% corpus 30.3% · below corpus mean (-19.1 pp)
  • MALF 86.8% corpus 64.8% · above corpus mean (+21.9 pp)

Lead product-problem code Break is 40% of coded problems · Lead manufacturer DEPUY MITEK LLC US accounts for 86% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Instrument, Ligature Passing And Knot Tying in the event-volume neighbourhood

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

reports

What this shows Instrument, Ligature Passing And Knot Tying carries 635 MAUDE reports, ranked #809 of 1000.

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

Event Types

Malfunction 551 (86.8%)
Injury 71 (11.2%)
Death 6 (0.9%)
Other 6 (0.9%)
1 (0.2%)

Patient Outcomes

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

525 (80.5%)
Other 47 (7.2%)
Required Intervention 38 (5.8%)
R 12 (1.8%)
Hospitalization 9 (1.4%)
Death 6 (0.9%)
L 5 (0.8%)
O 3 (0.5%)
Life Threatening 3 (0.5%)
H 2 (0.3%)
S 1 (0.2%)
Congenital Anomaly 1 (0.2%)

Top Product Problems

Break 206
Material Deformation 77
Adverse Event Without Identified Device or Use Problem 22
Detachment of Device or Device Component 21
Device-Device Incompatibility 21
Misfire 19
Difficult to Advance 16
Failure to Cut 16
Use of Device Problem 16
Unintended Movement 14
Insufficient Device Problem Information 13
Device Operates Differently Than Expected 11
Failure to Fire 11
Mechanical Problem 11
Tip breakage 11
Material Twisted/Bent 9
Difficult to Open or Close 8
Mechanical Jam 7
Defective Device 6
Entrapment of Device 6

Yearly Trend

95
1995: 1
98
1998: 1
00
2000: 2
02
2002: 1
04
2004: 2
05
2005: 1
07
2007: 1
10
2010: 3
11
2011: 4
12
2012: 3
13
2013: 11
14
2014: 17
15
2015: 6
16
2016: 10
17
2017: 8
18
2018: 66
19
2019: 40
20
2020: 27
21
2021: 46
22
2022: 68
23
2023: 57
24
2024: 124
25
2025: 78
26
2026: 58

Reports in 2025 (78) held close to the prior two-year average of 91.

Related Entities for Instrument, Ligature Passing And Knot Tying

Top Manufacturers

DEPUY MITEK LLC US 300
TELEFLEX MEDICAL 29
DEPUY MITEK 18

Event Locations

341 (53.7%)
HOSPITAL 154 (24.3%)
I 126 (19.8%)
NO INFORMATION 12 (1.9%)
NOT APPLICABLE 1 (0.2%)
OTHER 1 (0.2%)

Compare DEPUY MITEK LLC US vs TELEFLEX MEDICAL →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Instrument, Ligature Passing And Knot Tying: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (635 here).

Polymer Patient Examination Glove 635 Elevator, Surgical, Dental 638 Outpatient Cardiac Telemetry 638 Table 638

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Applicator, Absorbent Tipped, Non-Sterile 6 Cable, Electrode 6 Catheter, Straight 6 Dilator, Catheter, Ureteral 6

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

Disclaimer: MAUDE figures for Instrument, Ligature Passing And Knot Tying 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 Instrument, Ligature Passing And Knot Tying; 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.