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

Catalog Number	5551000
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample evaluation found no evidence of heat damage or flare ups to the internal components that would have resulted in the alleged smoking / smoke smell emitting.The damage to the internal components (kinked membrane switch cable and partially detached capacitors) found is not the result of a manufacturing issue.No manufacturing anomalies were found.The most probable root cause is due to physical trauma and / or unit being opened and tampered with while in service.All 3 voids seals were found broken.The unit was in service for 1+ years in good working condition prior to the reported event.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification.
Event or Problem Description
As reported, during a procedure on (b)(6) 2021 while using a bard/davol x-stream controller, the or staff noticed an odor, like smoke emission from the controller.No fire was reported, more like an electrical odor.As reported, the or removed the controller and replaced it with another controller to complete the case.As reported, there was no patient or user harm and the controller was given to the biomed dept.As reported, biomed tested the device and did not smell any smoke; however, noted the lo and hi leds would not illuminate.

• Brand Name: X-STREAM CONTROLLER
• Common Device Name: LAPAROSCOPIC, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11723622
• Report Number: 1213643-2021-20094
• Device Sequence Number: 3895316
• Product Code: GCJ
• UDI-Device Identifier: 00801741010118
• UDI-Public: (01)00801741010118
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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: DACZNX01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/26/2021
• 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