• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GMBH ERAGON MODULAR HANDLE PISTOL SHAPED MONOPOLAR

  • 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
 

RICHARD WOLF GMBH ERAGON MODULAR HANDLE PISTOL SHAPED MONOPOLAR Back to Search Results
Model Number 83930074
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/19/2020
Event Type  Malfunction  
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameERAGON MODULAR
Type of DeviceHANDLE PISTOL SHAPED MONOPOLAR
Manufacturer (Section D)
RICHARD WOLF GMBH
pforzheimer strasse 32
knittlingen, 75438
GM 75438
Manufacturer (Section G)
RICHARD WOLF GMBH
pforzheimer strasse 32
knittlingen, 75438
GM 75438
Manufacturer Contact
heiko seider-biederman
pforzheimer strasse 32
knittlingen, 75438
GM   75438
MDR Report Key10244774
Report Number9611102-2020-00010
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK935270
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number83930074
Device Catalogue Number83930074
Device LOT Number1448940
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/08/2020 Patient Sequence Number: 1
-
-