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 Power Up (1476); Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation identified areas of physical damage on the outer casing.The void seal was broken, indicating the controller may have been opened.The unit was sold to the user in december of 2016.Based on the 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.The information provided by bard 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 bard.
Event or Problem Description
It was reported per the customer contact that during testing, the x-stream controller would not power on.There was no patient involvement.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: 7625222
• Report Number: 1213643-2018-02091
• Device Sequence Number: 18876612
• 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): 06/21/2018

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: DAAVNX01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1