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); Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the subject product found physical damage to the controller as the outer case was cracked, and the pole clamp fractured.The void seal was broken, indicating the controller may have been opened.The biomed engineer was contacted as it was noted that there was a calibration sticker on the unit indicating it was assessed in (b)(6) 2018.He reported that he does not believe the unit was opened, and that he performed the assessment of the unit in (b)(6).He confirmed the controller was in good condition at that time, and there was no functional issues.He stated that based on the condition he suspects the unit was dropped or physically damaged between cases.He confirmed that there was no reported short circuit of the unit.He was told it simply did not power on.Based on evaluation we have concluded that the physical damage and the heat damage identified with the internal components was 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 that during set up of a procedure after inserting an x-stream tubing set into an x-stream controller, the device 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.It was reported by the biomed contact that it was possible the unit was dropped or damaged in use.The staff will change them on the pole and they can see some trauma between cases.There was no report of a short circuit, smoke, or flame having 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: 7395286
• Report Number: 1213643-2018-00883
• Device Sequence Number: 10932697
• Product Code: GCJ
• UDI-Device Identifier: 00801741010118
• UDI-Public: (01)00801741010118
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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: 03/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1