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

Catalog Number	5551000
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Failure to Prime (1492)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device had been in use at the user facility for more than 2-years.Visual evaluation of the subject product found thermal damage to internal components.The membrane switch ribbon cable is in close proximity to the control board (u2 logic chip).The heat damage on the chip was located on the surface directly under the ribbon.While there was space between the chip and the ribbon, it appears that heat build up resulted in thermal damage to the internal components.There was no identification of a manufacturing/material defect.A review of the manufacturing records was performed for the reported lot/serial number and found the lot was manufactured to specification.
Event or Problem Description
It was reported that in preparation for a procedure when attempting to prime the x-stream controller, once the irrigation button was pressed, the prime light illuminates however the controller will not do anything past the prime stage.Another controller was used in the case with the tubing set.There was no patient injury or intervention as a result of the problem experienced.The subject product was returned and evaluation identified that some internal components had heat damage.There was no report of a short circuit, smoke, or flame having occurred during use of the device.

• Brand Name: X-STREAM LAPAROSCOPIC IRRIGATION 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: 9710919
• Report Number: 1213643-2020-01244
• Device Sequence Number: 3098548
• Product Code: GCJ
• UDI-Device Identifier: 00801741010118
• UDI-Public: (01)00801741010118
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2020

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 Catalogue Number: 5551000
• Device Lot Number: DABENX01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1