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: NOVADAQ TECHNOLOGIES PINPOINT LIGHT CABLE; LAPAROSCOPE, GENERAL & 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
 

NOVADAQ TECHNOLOGIES PINPOINT LIGHT CABLE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number PC9004
Device Problem Off-Label Use (1494)
Patient Problems Death (1802); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2020
Event Type  Death  
Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that there was patient death.Please note that there is no alleged deficiency with the reported devices and it cannot be determined at this time, which, if any, of the reported devices may have caused or contributed to patient outcome.
 
Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: "none of the products are defective/faulty or were involved at the time of death.Patient died during open colon interposition surgery.Products were placed in the thorax only to illuminate.During the surgery, the light guide cable, lens and camera were used to illuminate deeper into the patient's open thorax (to help the doctors see better).The devices are demo goods from our sales rep.Our sales rep was present during the surgery." probable root cause: according the the customer provided event description, no failure or malfunction was associated with the pinpoint system.The patient death which occurred during the case was a separate issue not related to any of the pinpoint devices.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
 
Event Description
It was reported that there was patient death.Please note that there is no alleged deficiency with the reported devices and it cannot be determined at this time, which, if any, of the reported devices may have caused or contributed to patient outcome.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PINPOINT LIGHT CABLE
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
NOVADAQ TECHNOLOGIES
8329 eastlake drive, unit 101
burnaby
british columbia V5A 4 W2
CA  V5A 4W2
MDR Report Key10532268
MDR Text Key206867555
Report Number3012345110-2020-00007
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier00858701006568
UDI-Public00858701006568
Combination Product (y/n)N
PMA/PMN Number
K150956
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPC9004
Device Catalogue NumberPC9004
Was Device Available for Evaluation? No
Date Manufacturer Received08/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age60 YR
-
-