MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	5552002
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the returned sample found the acrylic base had detached from the nd handle valve body.The acrylic base is welded to the valve body.Visual inspection noted the weld appeared incomplete.This allowed the base to detach as was reported.The base assembly includes two springs that allow for compression and retraction of the suction and irrigation buttons.The internal springs are under tension when assembled in the valve body.When the valve body detached, the tension from the springs allowed the components to release.Based on our evaluation we have identified the most likely root cause to be manufacturing related.As reported, no harm presented as a result of the detached components.To date, this is the first complaint for this production lot of (b)(4) units released for distribution in april of 2018.A review of the manufacturing records was performed and found that this lot was manufactured to specification.A review of complaint history finds this to be the only report of a detached base for the x-stream tubing sets.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 by the user facility that the x-stream tubing set was used successfully for about an hour during a laparoscopic cholecystectomy "when the small piece directly opposite to the trigger/buttons of suction irrigator flew off and struck the resident in the trachea".The attending physician had the instrument in her hand but wasn¿t sure that she was actually pressing on either button (suction or irrigation) at the time of the event.Another device was opened to complete the case.The sample return identified a detachment of the base of the nd handle below the suction/irrigation button.There was no harm that presented as a result of the problem experienced.

• Brand Name: X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM
• 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: 7934468
• Report Number: 1213643-2018-03424
• Device Sequence Number: 19248783
• Product Code: GCJ
• UDI-Device Identifier: 00801741010095
• UDI-Public: (01)00801741010095
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/04/2018

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 5552002
• Device Lot Number: JUCQF336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 67