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Clamp, Circumcision

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Clamp, Circumcision

The FDA MAUDE database aggregates 836 adverse-event reports for Clamp, Circumcision spanning the period from 1992 through 2026. Of these, 5 are classified as death reports, 422 as injury reports, and 346 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 12 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Device Handling Problem topping the list at 104 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 147 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 9 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

836
Total Reports
5
Death Reports
422
Injury Reports
346
Malfunctions

Event Types

Injury 422 (50.5%)
Malfunction 346 (41.4%)
Other 43 (5.1%)
20 (2.4%)
Death 5 (0.6%)

Patient Outcomes

Required Intervention 315 (35.9%)
276 (31.4%)
Other 208 (23.7%)
R 27 (3.1%)
Hospitalization 26 (3.0%)
S 7 (0.8%)
O 5 (0.6%)
Death 5 (0.6%)
Disability 5 (0.6%)
Life Threatening 2 (0.2%)
H 1 (0.1%)
L 1 (0.1%)

Top Product Problems

Device Handling Problem 104
Insufficient Information 93
Product Quality Problem 60
Device Dislodged or Dislocated 49
Appropriate Term/Code Not Available 36
Adverse Event Without Identified Device or Use Problem 34
Use of Device Problem 27
Improper or Incorrect Procedure or Method 19
Material Too Soft/Flexible 19
Device Operates Differently Than Expected 12
No Apparent Adverse Event 12
Scratched Material 12
Fitting Problem 10
Flaked 9
Mechanical Problem 9
Difficult to Open or Close 7
Loss of or Failure to Bond 7
Pressure Problem 7
Sharp Edges 7
Lack of Effect 6

Yearly Trend

92
1992: 4
93
1993: 7
94
1994: 6
95
1995: 13
96
1996: 15
97
1997: 17
98
1998: 21
99
1999: 20
00
2000: 12
01
2001: 20
02
2002: 10
03
2003: 8
04
2004: 9
05
2005: 11
06
2006: 8
07
2007: 17
08
2008: 6
09
2009: 20
10
2010: 21
11
2011: 12
12
2012: 14
13
2013: 16
14
2014: 20
15
2015: 21
16
2016: 147
17
2017: 25
18
2018: 13
19
2019: 11
20
2020: 22
21
2021: 5
22
2022: 3
23
2023: 33
24
2024: 121
25
2025: 122
26
2026: 6

Related Entities for Clamp, Circumcision

Event Locations

382 (45.7%)
HOSPITAL 214 (25.6%)
I 184 (22.0%)
NO INFORMATION 29 (3.5%)
INVALID DATA 17 (2.0%)
OTHER 4 (0.5%)
UNKNOWN 3 (0.4%)
NOT APPLICABLE 2 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare CIRC MEDTECH vs ALLIED MEDICAL LLC. →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.