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); Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, x-stream controller irrigation pump caught fire in the or.The subject controller, including the power cord, has been returned for evaluation; however, at this time evaluation is not yet completed.Preliminary evaluation noted the 3 void seals intact, indicating the controller had not been tampered with or attempted to be opened.The male end of the power cord (the end that connects to the ac outlet) is in good condition.The back of the returned controller is heat damaged at and near the power source connection area, and the female plug adapter on the power cord is charred and melted.The dhr review showed the pump was functionally tested and observed to be operating properly.This controller showed no indications of failure based on successful completion of the final quality test.In addition, the dhr review indicates that there were no deviations to the device specifications, process specifications, quality assurance procedures or work instructions.Based on the information available at this time, the root cause of the event has not been determined.When sample evaluation is completed, a supplemental mdr will be submitted.
Event or Problem Description
As reported, the bard/davol x-stream irrigation controller was found to have caught fire in the or when there was no staff present (off hours 9:00 p.M.- 2:00 a.M.) on (b)(6) 2021.The fire alarm went off and the security was able to secure the scene.There was no harm to any persons and no additional damage to any of the surrounding materials in the or.It was reported it looked like the electrical connector overheated, burned and also scorched the power panel on the back of the device.As reported, the power cord is always connected to the wall source (hospital grade ac outlet) and never unplugged.
Additional Manufacturer Narrative
As reported, x-stream controller irrigation pump caught fire in the or.The subject controller, including the power cord, has been returned for evaluation; however, at this time evaluation is not yet completed.Preliminary evaluation noted the 3 void seals intact, indicating the controller had not been tampered with or attempted to be opened.The male end of the power cord (the end that connects to the ac outlet) is in good condition.The back of the returned controller is heat damaged at and near the power source connection area, and the female plug adapter on the power cord is charred and melted.The dhr review showed the pump was functionally tested and observed to be operating properly.This controller showed no indications of failure based on successful completion of the final quality test.In addition, the dhr review indicates that there were no deviations to the device specifications, process specifications, quality assurance procedures or work instructions.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of device evaluation.A forensic evaluation of the device was conducted.Review notes the ground pin was fully inserted into the connection, indicating the connection was properly seated.Some environmental mechanism allowed a conductive path between the hot conductor and the ground conductor within the corded line set and socket assembly.As a result of this environmental contamination, a semi conductive path was created.This allowed for electricity to travel in an unattended path.This produced sufficient heat and arcing between the components resulting in the problem reported.Based on the sample evaluation and investigation performed, it was concluded that an environmental contaminant influenced the conductivity between the hot components and the ground components within the corded receptacle and socket interface.The electrical event was not related to any shortcoming of the design, manufacture, of the x-stream controller.A review of the device history records confirmed the device was manufactured to specification.The device is reusable and is cleaned and maintained at the user facility.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in april 2020.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, the bard/davol x-stream irrigation controller was found to have caught fire in the or when there was no staff present (off hours 9:00 p.M.- 2:00 a.M.) on (b)(6) 2021.The fire alarm went off and the security was able to secure the scene.There was no harm to any persons and no additional damage to any of the surrounding materials in the or.It was reported it looked like the electrical connector overheated, burned and also scorched the power panel on the back of the device.As reported, the power cord is always connected to the wall source (hospital grade ac outlet) and never unplugged.

• 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: 12129552
• Report Number: 1213643-2021-20175
• Device Sequence Number: 14343818
• Product Code: GCJ
• UDI-Device Identifier: 00801741010118
• UDI-Public: (01)00801741010118
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: DAEQNX01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2020
• 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