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	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While using the m-close device, it was noticed that part of it, specifically the loop wire, was missing.Ct and x-ray were completed on the patient, negative for foreign body.

• 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: 24442245
• Report Number: 24442245
• Device Sequence Number: 10443506
• Product Code: HCF
• UDI-Device Identifier: 00850009417022
• UDI-Public: (01)00850009417022
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/16/2026
• Report Date (Section F): 02/16/2026

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: A0926
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Date Report Sent to FDA: 02/16/2026