MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 X-STREAM CONTROLLER; LAPAROSCOPIC, GENERAL & PLASTIC SURGERY

Catalog Number	5551000
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Device Remains Activated (1525)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device had been in service for this device is less than 1 + year.Visual evaluation of the subject product found thermal damage to an internal component (u2 logic chip).Heat damage is present on the u2 component with evidence of overheating on the power supply heatsink.The heat damage on the chip was located on the surface.The damage to the internal component described above is causing the functional issue reported.There was no identification of a manufacturing/material defect.Sample evaluated.
Event or Problem Description
As reported, during a procedure on (b)(6) 2021, the bard/davol x-stream controller was continuously running without shut off.The operating room staff replaced the controller to complete the case.As reported, one tubing set was used with the controller and the device was not tested.As reported, there is no physical damage, the void seal is not broken and the staff is familiar with the use of the device.There was no reported patient injury.Sample evaluation identified heat damage to internal components.

• Brand Name: X-STREAM CONTROLLER
• Common Device Name: LAPAROSCOPIC, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11281943
• Report Number: 1213643-2021-20018
• Device Sequence Number: 3721276
• Product Code: GCJ
• UDI-Device Identifier: 00801741010118
• UDI-Public: (01)00801741010118
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2021

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 Catalogue Number: 5551000
• Device Lot Number: DACQNX01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other