MAUDE Adverse Event Report: NOVADAQ TECHNOLOGIES PINPOINT LAPAROSCOPE - 10MM, STANDARD, 30 WITH WOLF AND STORZ ADAPTOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SC9134
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
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 the procedure was rescheduled.
Event or Problem Description
It was reported that the procedure was rescheduled.
Additional Manufacturer Narrative
Alleged failure: "during using the cpr a patient was burnt.Customer found greyish before use." probable root cause: as per manufacturer, the physical damage was most likely caused by customer use and handling of the laparoscope as the laparoscope was inspected before being distributed to customer.The device was returned for investigation and the reported failure mode was not confirmed.The reported failure mode will be monitored for future re occurrence.For information and warnings related to the proper use and maintenance of this device, please reference and adhere to information presented in the associated product ifu.Manufacture date is not known.

• Brand Name: PINPOINT LAPAROSCOPE - 10MM, STANDARD, 30 WITH WOLF AND STORZ ADAPTOR
• 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: 9593593
• Report Number: 3012345110-2020-00001
• Device Sequence Number: 16266361
• Product Code: GCJ
• UDI-Device Identifier: 00858701006063
• UDI-Public: 00858701006063
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SC9134
• Device Catalogue Number: SC9134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other