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); Use of Device Problem (1670)
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 and the led's would not illuminate as was reported.The evaluation identified areas of physical damage on the outer casing and the void seal was broken, indicating the controller may have been opened.Heat damage was identified inside the unit at the control board (logic chip) and the membrane ribbon was found melted.The unit was sold to the user in (b)(6)2016.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.
Event or Problem Description
It was reported that during set up of an unspecified procedure, the operating room (or) staff noticed the x-stream controller would not function in the hi or lo setting and the led lights would not illuminate.The or staff used another controller for the case.There was no patient involvement.The device was sent to the biomed dept.With the same results.The subject product was returned to davol for evaluation and the 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.

• 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: 8182201
• Report Number: 1213643-2018-04895
• Device Sequence Number: 1734197
• Product Code: GCJ
• UDI-Device Identifier: 00801741010118
• UDI-Public: (01)00801741010118
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/19/2018

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: DAATNX01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1