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

Model Number	8886828006
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2018
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 procedure, the tip of the catheter suddenly sparked.The procedure was completed with another device.No patient harm.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device all connections to handle had separated from the handle (this includes: the irrigation).Signs of adhesive shearing was observed on the bulb and wiring fixture.The bulb was found to be broken.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 root cause of the reported condition may be cause by broken bulb\damaged light fixture.Bulb breakage or damage to the light fixture may be caused by applying excessive force or manipulated the device beyond indicated use.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.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): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7654504
• Report Number: 1219930-2018-03533
• Device Sequence Number: 19421892
• Product Code: HBI
• UDI-Device Identifier: 10884521176089
• UDI-Public: 10884521176089
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K883201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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 Model Number: 8886828006
• Device Catalogue Number: 8886828006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1