MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA VITAL VUE; ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD

Model Number	8886828006
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic procedure, the blue part of the device has heated and melted.It was stated that smoke appeared.The device has been turned off.There was no patient injury.

• Brand Name: VITAL VUE
• Common Device Name: ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 9982425
• Report Number: 1282497-2020-00013
• Device Sequence Number: 19954009
• Product Code: HBI
• UDI-Device Identifier: 10884521176089
• UDI-Public: 10884521176089
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K883201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2020

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 Expiration Date: 06/30/2023
• Device Model Number: 8886828006
• Device Catalogue Number: 8886828006
• Device Lot Number: 182080012K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1