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

Model Number	8886828206
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/02/2019
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 anterior cervical discectomy and fusion, the device melted on table.Another device was opened and did the case.The problem was discovered before the product was used on the patient.
Additional Manufacturer Narrative
Additional information: d10, g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted that the device handle had been melted and the power source inside the handle had been severed in half.Functional testing could not be done based on the condition the device was returned in.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.A definitive root cause could not be determined with regard to the reported condition due to not being able to test because the devices power source was damaged.If information is provided in the future, a supplemental report will be issued.

• 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: 9213611
• Report Number: 2936999-2019-00882
• Device Sequence Number: 2708112
• Product Code: HBI
• UDI-Device Identifier: 10884521176102
• UDI-Public: 10884521176102
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K883201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 02/29/2024
• Device Model Number: 8886828206
• Device Catalogue Number: 8886828206
• Device Lot Number: 190880219K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 81