MAUDE Adverse Event Report: NEW WAVE ENDO M-CLOSE KIT; INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Model Number	27-101
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
M-close device not firing properly when inserted into patient.Surgeon inserted m-close device, attempted to deploy, however m-close device was defective.No harm done to patient.

• Brand Name: M-CLOSE KIT
• Common Device Name: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): NEW WAVE ENDO; 6601 lyons road; unit d8; coconut creek FL 33073
• MDR Report Key: 17540044
• Report Number: 17540044
• Device Sequence Number: 6344179
• Product Code: HCF
• UDI-Device Identifier: 00850009417022
• UDI-Public: (01)00850009417022
• 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): 05/11/2023
• Report Date (Section F): 05/11/2023

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
• Device Model Number: 27-101
• Device Catalogue Number: 27-101
• Device Lot Number: C1523
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 05/11/2023