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 Prime (1492)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject product evaluation found the unit would not irrigate as was reported.Visual evaluation identified areas of physical damage on the outer casing and all three of the void seals were broken, indicating the controller may have been opened.There was a loose piece of black plastic inside of the housing from one of the power supply board components.The ribbon cable was found kinked and in close proximity to the control board (logic chip) where heat damage was identified.The damage to the internal components described above is causing the failures found.It appears likely that an electrical event occurred causing the heat damage to the logic chip component.As the device was in service for approximately 8 months, there was no evidence of a manufacturing defect.Based on evaluation we have concluded that the physical damage and the heat damage identified with the internal components was most likely due to the device being subjected to physical trauma.A review of the manufacturing records was performed for the reported lot/serial number and found the lot was manufactured to specification.
Event or Problem Description
It was reported per the customer contact that during the set up of a procedure before use the x-stream controller would not allow for any irrigation fluid to flow into the tubing set.Another controller was used in the case, with the tubing set.There was no patient injury or intervention as a result of the problem experienced.The subject product was returned and evaluation identified that some internal components had heat damage.There was no report of a short circuit, smoke, or flame having occurred during use of the device.

• 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: 9251620
• Report Number: 1213643-2019-10357
• Device Sequence Number: 2003131
• Product Code: GCJ
• UDI-Device Identifier: 00801741010118
• UDI-Public: (01)00801741010118
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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: DABWNX01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1