MAUDE Adverse Event Report: NOVADAQ TECHNOLOGIES SPY-PHI PACK; COVER, BARRIER, PROTECTIVE

Catalog Number HH9006

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the sterile drape was not sealed completely.No adverse consequences were reported.

Manufacturer Narrative

Alleged failure: "spy phi drape isn't sealed correctly".Probable root cause/s: reported issue is likely due to a failure of the bottom pouch seal.This seal is applied in-house by drape oem premier guard and oem investigation is ongoing to determine root cause.Nonconformance pr# (b)(4) was opened to document results of investigation and determine additional actions.The product was not returned for investigation but the reported failure mode was confirmed via investigation findings from pr# (b)(4).The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.

Event Description

It was reported that the sterile drape was not sealed completely.No adverse consequences were reported.

• Brand Name: SPY-PHI PACK
• 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: 9214462
• MDR Text Key: 217338544
• Report Number: 3012345110-2019-00010
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2022
• Device Catalogue Number: HH9006
• Device Lot Number: 1906241
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1