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: VISUALASE; POWERED LASER SURGICAL INSTRUMENT
  • 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
 

VISUALASE; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Model Number 9735560
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/08/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The tubing was returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed.No leaks were observed.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information regarding a thermal therapy system being used for a neuro soft tissue ablation procedure.It was reported that intra-operatively, the irrigation tubing had a leak near the pump.This caused a delay of less than one hour and no system damage.The procedure was completed and there was no reported impact to patient outcome.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VISUALASE
Common Device Name
POWERED LASER SURGICAL INSTRUMENT
MDR Report Key12720312
Report Number1045254-2021-00600
Device Sequence Number4028738
Product Code GEX
UDI-Device Identifier00763000218188
UDI-Public00763000218188
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K053087
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/29/2021
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 Expiration Date12/17/2022
Device Model Number9735560
Device Catalogue Number9735560
Device Lot Number0221409315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/08/2021
Initial Report FDA Received Date10/29/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured12/17/2020
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 Age37 YR
Patient Weight84
-
-