Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEW DEANTRONICS LTD VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NEW DEANTRONICS LTD VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES Back to Search Results
Model Number E3781R-28ASP
Medical Device Problem Codes Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/13/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during a procedure, the device had insufficient adhesion.Insulation sheath came off from the point of use.Another device was used and it worked fine.There was no patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VALLEYLAB
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
Manufacturer (Section D)
NEW DEANTRONICS LTD
12f no 51 sec 4 chong yang ro
taipe,co 23675
TW  23675
MDR Report Key12557263
Report Number1717344-2021-01334
Device Sequence Number19910120
Product Code GEI
UDI-Device Identifier10884521767805
UDI-Public10884521767805
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K183594
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/30/2021
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 Model NumberE3781R-28ASP
Device Catalogue NumberE3781R-28ASP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/13/2021
Initial Report FDA Received Date09/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-