MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. X-STREAM CONTROLLER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	5551000
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mw5088440 did not identify include contact information or identify the user facility.As such we were unable to request the sample or gather any additional information.The x-stream controller is a re-usable device.The product lot number/serial number was not provided, as such the manufacturing records could not be reviewed.No definitive conclusion can be made at this time as to the root cause of the unit smoking.Shall more information or the sample be obtained, a supplemental mdr will be submitted.Unknown if device is available.
Event or Problem Description
Per medwatch# 5088440 that during a surgical procedure, the suction irrigator machine started to smoke.Machine stopped and removed.Machine sent for evaluation.Unk.Etiology of cause.

• Brand Name: X-STREAM CONTROLLER
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9071111
• Report Number: 1213643-2019-08831
• Device Sequence Number: 3762531
• Product Code: GCJ
• UDI-Device Identifier: 00801741010118
• UDI-Public: (01)00801741010118
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K001790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5551000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1