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 Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during set-up of a procedure, the bard/davol x-stream controller would not power on.As reported, the device was tested by the biomed who confirmed the device had no power after inserting a tubing cassette used specifically for testing.It is reported that the fuses were good, void seals are intact and there was no damage noted to the device.As reported, there was no patient involvement.Sample evaluation identified heat damage to internal components.
Additional Manufacturer Narrative
Visual evaluation of the subject product found thermal damage to internal components (ribbon cable - membrane and u2 logic chip).The heat damage on the chip was located on the surface directly under the ribbon.And while there was space between the chip and the ribbon, heat buildup resulted in thermal damage of the components.The damage to the internal components caused the functional issue reported.The device had been in use for approx.2-years.There was no identification of a manufacturing/material defect.Review of manufacturing records confirms product was manufactured to specification.Sample evaluated.

• 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
• Manufacturer (Section G): NEXTPHASE MEDICAL DEVICES -3007199740; 150 hopper ave.; waldwick NJ 07463
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 12785860
• Report Number: 1213643-2021-20400
• Device Sequence Number: 5155853
• Product Code: GCJ
• UDI-Device Identifier: 00801741010118
• UDI-Public: (01)00801741010118
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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: DACWNX01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown