MAUDE Adverse Event Report: NEXTPHASE MEDICAL DEVICES -3007199740 X-STREAM CONTROLLER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	5551000
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The physical condition of the returned sample (controller) is unremarkable with no sign of damage.Examination of the electric contacts inside the cradle identified no physical damage or corrosion.No loose components were identified inside of the housing.The male pins on the controller are discolored from dried saline and/or corrosion.The returned power cord is blacked at the female end as reported.It is likely that the controller male pins were wet prior to plugging in the power cord to the back of the controller, and when activated, heat was generated, causing the blackening of the power cord.Based on the sample evaluation and investigation performed, the reported event was confirmed and root cause is most reasonably determined to be use-related.Review of manufacturing records indicate product was manufactured to specification.
Event or Problem Description
As reported, during the set up of an unknown procedure, the or staff noted the back of the x-stream controller power cord plug was charred/corroded and black in appearance.It was also reported that the biomed tech checked the fuses and stated that they appeared to be fine without any issue.

• Brand Name: X-STREAM CONTROLLER
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): NEXTPHASE MEDICAL DEVICES -3007199740; 150 hopper ave.; waldwick NJ 07463
• MDR Report Key: 10975376
• Report Number: 1213643-2020-20069
• Device Sequence Number: 703401
• Product Code: GCJ
• UDI-Device Identifier: 00801741010118
• UDI-Public: (01)00801741010118
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/18/2020

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 Catalogue Number: 5551000
• Device Lot Number: DADTNX01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/09/2020
• 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