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	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The device would not complete the second click to complete the closure.

• 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: 22814542
• Report Number: 22814542
• Device Sequence Number: 18332036
• Product Code: HCF
• UDI-Device Identifier: 00850009417053
• UDI-Public: (01)00850009417053(17)20260220(10)B0725
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2025
• Report Date (Section F): 08/07/2025

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 Model Number: 27-101
• Device Catalogue Number: 27-101
• Device Lot Number: B0725
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Date Report Sent to FDA: 08/07/2025