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

Catalog Number 5551000

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 280568266
• Report Number: 1213643-2021-20400
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00801741010118
• UDI-Public: (01)00801741010118
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other