MAUDE Adverse Event Report: NOVADAQ TECHNOLOGIES PINPOINT LIGHT CABLE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	PC9004
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that there was a thermal event associated with the light cable.
Event or Problem Description
It was reported that there was a thermal event associated with the light cable.
Additional Manufacturer Narrative
Alleged failure: "right at the beginning of the medical procedure, the novadaq fiber optic cable unintentionally disconnected itself from the optical connector (with the whitish mode switched on).The cable fell on paper and was so hot that the paper immediately started to smoke.It has been noticed that the light cable end is always very hot when the white light mode is on (it was tested without being connected to lenses).The internal light setting is set to the standard setting of 192." probable root cause: vpi output levels cannot be confirmed without product return for investigation.The light guide cable connection fit and tightness cannot be verified without product return.Under normal conditions the cable requires a significant amount of force to disengage as reported.The pinpoint system (light guide cable and laparoscope) are known and expected to become fairly hot to the touch with extended use, there are numerous warnings in the product instructions for use which warn against direct contact during use or immediately after.One failure mode we have seen in the past is caused by leftover debris and residue at the scope/light guide end points from insufficient/improper cleaning post sterilization and reprocessing.This can lead to excess heat and smoke being emitted from the overheating leftover debris.The product was not returned for investigation and the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.

• Brand Name: PINPOINT LIGHT CABLE
• Common Device Name: 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 Key: 8390580
• Report Number: 3012345110-2019-00002
• Device Sequence Number: 2989317
• Product Code: GCJ
• UDI-Device Identifier: 00858701006568
• UDI-Public: 00858701006568
• Combination Product (Y/N): N
• PMA/510(K) Number: K150956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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 Catalogue Number: PC9004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1