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 Pump (1502)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample evaluation found the physical condition of the controller is unremarkable with no sign of damage to the outer casing, pole clamp, etc.No outer components were found to be missing and no loose components were noted inside of the housing.No abnormal wear or corrosion was found on the controller contacts.There was no evidence of fluid ingress noted in the housing.Heat damage was identified on the u2 component on the pcb and the lo/hi membrane ribbon.The membrane ribbon cable is found to be kinked in the area of the heat damage.The kink resulted in the membrane cable coming into contact with u2 component.The c6 and c7 capacitors are found to be lifting off of the board in the area where each are soldered to the board.The damage to the internal components described above is causing the failures found.It appears likely that an electrical event occurred causing he heat damage to the ribbon cable and u2 component.The partially disconnected c6 and c7 capacitors could also be a contributing factor.Heat damage prevents further evaluation.As the device was in service for approximately 1 year there was no evidence of a manufacturing defect.A definitive root cause as to why the heat damage presented cannot be determined at this time.
Event or Problem Description
It was reported per the customer contact that the x-stream controller was not working, the unit would not power on.There was no patient injury or intervention reported.The subject product was returned and evaluation identified that some internal components had heat damage with evidence of internal combustion having occurred.There was no report of a short circuit, smoke, or flame having occurred during use of the device.It is not known when the internal damage occurred.

• 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: 8744666
• Report Number: 1213643-2019-05583
• Device Sequence Number: 16803779
• Product Code: GCJ
• UDI-Device Identifier: 00801741010118
• UDI-Public: (01)00801741010118
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5551000
• Device Lot Number: DABWNX01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1