MAUDE Adverse Event Report: COVIDIEN LP VITAL VUE; ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD

Model Number	8886828106
Health Effect - Clinical Codes	Erythema (1840); Swelling (2091)
Date of Event	11/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During the case the vital vue suction was given to the sterile field.A one liter bag of saline was spiked and the tubing was attached to the suction machine.The surgeon draped the suction over the patients right thigh as it was used intermittently throughout the case.When hooking up the light source for the cystoscopy the nurse noted the vital vue was draped over the patients leg and asked the surgeon if the vital vue was on.The resident responded no, but did not move or check if the light was on.The nurse unplugged the tubing from the vital vue at that time and the case proceeded.At the end of the case the drapes were removed from the patient and the nurse noted a raised reddened area with blisters on the patients right inner thigh near the bovie pad site.The bovie pad was removed.The site was unchanged; no redness, swelling, or skin changes.

• Brand Name: VITAL VUE
• Common Device Name: ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7074260
• Report Number: 7074260
• Device Sequence Number: 1013736
• Product Code: HBI
• UDI-Device Identifier: 10884521176096
• UDI-Public: (01)10884521176096(17)210731(10)161900107M
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2017
• Report Date (Section F): 11/20/2017

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: Physician
• Device Expiration Date: 07/31/2021
• Device Model Number: 8886828106
• Device Catalogue Number: 8886828106
• Device Lot Number: 161900107M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VITAL VUE SINGLE USE YANKUER, VITAL VUE LIGHT SOUR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Date Report Sent to FDA: 11/20/2017