MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	5552003
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the x-stream laparoscopic irrigation tubing set leaked at the plastic reservoir.The subject product was returned for evaluation and confirmed for a fluid leak.Fluid has entered the motor housing going beyond the lip seal of the motor mount, into the battery compartment.Excessive sealant and cracks were identified on the motor mount which appears to be allowing fluid to leak through the motor; corrosion was also noted.Based on the investigation and sample evaluation, the root cause was assessed to be manufacturing related.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in july, 2020.Sample evaluated.
Event or Problem Description
As reported, during a set up of the procedure in the operating room on (b)(6) 2020, the x-stream laparoscopic irrigation tubing set with nezhat dorsey trumpet valve leaked at plastic reservoir.Another device was used to complete the procedure.The device was not used on patient; as such, there was no reported patient injury.

• Brand Name: X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10813714
• Report Number: 1213643-2020-20039
• Device Sequence Number: 11581851
• Product Code: GCJ
• UDI-Device Identifier: 00801741010101
• UDI-Public: (01)00801741010101
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: 06/28/2023
• Device Catalogue Number: 5552003
• Device Lot Number: JUET3041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other