MAUDE Adverse Event Report: NOVADAQ TECHNOLOGIES SPY-PHI DRUG DRAPE KIT; COVER, BARRIER, PROTECTIVE

Catalog Number HH9006

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

Novadaq technologies, inc.Was acquired by stryker.This mdr is being submitted late because it was identified during the integration and remediation activities initiated by stryker endoscopy in conjunction with this acquisition.The spy-phi drape is a sterile, single use drape intended to be placed over the spy-phi device and provide a sterile barrier of the imaging head so that the spy-phi device can be used in the sterile operating environment.The spy-phi device itself is intended to be used at a working distance of ¿10 to 40 cm (4 to 15 inches) from the surface or tissue to be imaged¿ in accordance with pg.58 of the spy-phi operator¿s manual.The breach in the drape material was observed after the device was inserted into the breast pocket of a patient by the operating surgeon.To date, novadaq has not received any reports of patient injury or infection as a result of hh2000 drape sterile barrier failure.This event was initially reported under the associated recall z-3236-2017.

Event Description

It was reported that pinhole leaks were found in the drape.No adverse consequences were reported.

Manufacturer Narrative

This investigation was completed by novadaq technologies, inc.Prior to their acquisition by stryker.The investigations were completed to novadaq's active procedure at that time, qsp 8.2-1 rev e, customer feedback & complaint handling.See attached investigation 17-cr-218.This complaint was transferred to trackwise to file an mdr as part of remediation activities and therefore will not undergo an investigation per dwi2508.

Event Description

It was reported that pinhole leaks were found in the drape.No adverse consequences were reported.

• Brand Name: SPY-PHI DRUG DRAPE KIT
• Type of Device: COVER, BARRIER, PROTECTIVE
• Manufacturer (Section D): NOVADAQ TECHNOLOGIES; 8329 eastlake drive, unit 101; burnaby; british columbia V5A 4 W2; CA V5A 4W2
• MDR Report Key: 7737479
• MDR Text Key: 115783878
• Report Number: 3012345110-2018-00006
• Device Sequence Number: 1
• Product Code: MMP
• Combination Product (y/n): N
• PMA/PMN Number: K041501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HH9006
• Device Lot Number: 1704F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1