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: TERUMO CARDIOVASCULAR SYSTEM CORP. TERUMO VIRTUOSSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYS; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

  • 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
 

TERUMO CARDIOVASCULAR SYSTEM CORP. TERUMO VIRTUOSSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYS; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Lot Number 97K
Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2020
Event Type  malfunction  
Event Description
Pa was using terumo endoscopic vein harvest disposable to retrieve saphenous vein graft from left leg.During the harvest, she asks if we smell something burning.The odor was emanating from where she was standing to harvest and was getting stronger, she pulled device out of incision, tip was blackened and appeared to have burnt on the end.Another device was obtained with same result.Both were kept with their original packaging and biomed was contacted.Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TERUMO VIRTUOSSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYS
Type of Device
LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEM CORP.
MDR Report Key9744520
MDR Text Key180900521
Report NumberMW5093196
Device Sequence Number1
Product Code GCJ
UDI-Public(01)00699759450769917)220630(10
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/19/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2022
Device Lot Number97K
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age55 YR
-
-