MAUDE Adverse Event Report: DAVOL INC. X-STREAM; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	5552003
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
X-stream laparoscopic irrigation tubing: the cap of the suction irrigator fell off.Occurred twice.

• Brand Name: X-STREAM
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): DAVOL INC.; 100 crossings blvd; warwick RI 02886
• MDR Report Key: 12546227
• Report Number: 12546227
• Device Sequence Number: 4032185
• Product Code: HET
• UDI-Device Identifier: 00801741010101
• UDI-Public: (01)00801741010101
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/15/2021
• Report Date (Section F): 09/15/2021

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: No Information
• Device Model Number: 5552003
• Device Catalogue Number: 5552003
• Device Lot Number: JUFR1380,
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/15/2021