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

Catalog Number 5551000

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2021

Event Type  malfunction  

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 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
• Type of Device: LAPAROSCOPIC, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): NEXTPHASE MEDICAL DEVICES -3007199740; 150 hopper ave.; waldwick NJ 07463
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 11723622
• MDR Text Key: 247238725
• Report Number: 1213643-2021-20094
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00801741010118
• UDI-Public: (01)00801741010118
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other