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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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DEPUY MITEK LLC US VAPR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number 228370
Medical Device Problem Code Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/10/2026
Type of Reportable Event Malfunction
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Brand Name
VAPR
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
elba bello
325 paramount drive
raynham, MA 02767
9083863534
MDR Report Key25856265
Report Number1221934-2026-03167
Device Sequence Number5558323
Product Code GEI
UDI-Device Identifier10886705020935
UDI-Public(01)10886705020935(10)U2510001(17)281026
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K120095
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Company Representative
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number228370
Device Lot NumberU2510001
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/13/2026
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2026
Supplement Date Received by Manufacturer07/21/2026
08/13/2026
Initial Report FDA Received Date07/17/2026
Supplement Report FDA Received Date07/21/2026
08/13/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured10/06/2025
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Patient SexUnknown
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