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

Catalog Number	5551000
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, at the end of a case using the bard/davol x-stream irrigation controller pump, the contact was trying to determine what caused one of the operating rooms electrical circuit breakers to trip.As reported, the location of the power cord was moved to a functional electrical outlet and at that moment an electrical arc flashed; melted power cord and ac input parts were noted.As reported, is unknown if fluid was leaking from device before the arc.As reported, the power cord used was the same as that supplied with the unit and was plugged into a hospital grade ac outlet.
Additional Manufacturer Narrative
As reported, when the bard/davol x-stream controller irrigation pump was plugged into an electrical outlet, an electric arc flashed and melted parts were noted.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 void seal is intact, indicating the controller had not been tampered with or attempted to be opened.There is noticeable cracking at the corner housing screw locations and the pole clamp pads are worn from use.There were no loose components inside the housing.The unit is heat damaged at the power source/ male plug pins as reported.The female plug adapter on the power cord is charred and melted.Charring can be seen on the back ul label as well as the housing.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.Note, the date of event ((b)(6) 2022) is provided as a best estimate based on the date of awareness.Evaluation ongoing.
Event or Problem Description
As reported, at the end of a case using the bard/davol x-stream irrigation controller pump, the contact was trying to determine what caused one of the operating rooms electrical circuit breakers to trip.As reported, the location of the power cord was moved to a functional electrical outlet and at that moment an electrical arc flashed; melted power cord and ac input parts were noted.As reported, is is unknown if fluid was leaking from device before the arc.As reported, the power cord used was the same as that supplied with the unit and was plugged into a hospital grade ac outlet.
Additional Manufacturer Narrative
As reported, when the bard/davol x-stream controller irrigation pump was plugged into an electrical outlet, an electric arc flashed and melted parts were noted.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 void seal is intact, indicating the controller had not been tampered with or attempted to be opened.There is noticeable cracking at the corner housing screw locations and the pole clamp pads are worn from use.There were no loose components inside the housing.The unit is heat damaged at the power source/ male plug pins as reported.The female plug adapter on the power cord is charred and melted.Charring can be seen on the back ul label as well as the housing.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.Note, the date of event (b)(6) 2022) is provided as a best estimate based on the date of awareness.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr was submitted to report the results of device evaluation.Based on the sample evaluation, it was concluded that an environmental event occurred that influenced the conductivity between the hot components and the ground components within the corded receptacle and socket interface for the x-stream controller.Evaluation of the sample found the unit is heat damaged at the power source/ male plug pins as reported.The female plug adapter on the power cord is charred and melted.Charring can be seen on the back ul label as well as the housing.Based on the time in service (6-years) and understanding of the failure mode, this appears to have been related to environmental factors.Possibly saline, or other residual material in the plug/cord location.However, at this time any evidence of material that may have been present was consumed.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.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.H3 other text : sample evaluated.

• Brand Name: X-STREAM CONTROLLER
• Common Device Name: LAPAROSCOPE, 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: 13666659
• Report Number: 1213643-2022-00045
• Device Sequence Number: 4893657
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: DAZHNX01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2015
• 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