MAUDE Adverse Event Report: THE O R COMPANY PTY LTD SUTURE PASSOR PRO¿, 150MM SUTURE PASSOR, ONE 10-12MM GUIDE AND TWO TROCAR SWABS; SUTURE PASSER

Model Number	RSG-14F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.Once additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "the sheath portion of the device disengaged upon surgeons attempting to use, bending the device and causing the sheath and main part of device to come apart into two pieces as it was being pulled out of the patient.".

• Brand Name: SUTURE PASSOR PRO¿, 150MM SUTURE PASSOR, ONE 10-12MM GUIDE AND TWO TROCAR SWABS
• Common Device Name: SUTURE PASSER
• Manufacturer (Section D): THE O R COMPANY PTY LTD; 4/47 wangara road; cheltenham, victoria 3192 ; AS 3192
• Manufacturer Contact: justin abraham ; 4/47 wangara road; cheltenham, victoria 3192 ; AS 3192
• MDR Report Key: 25250493
• Report Number: 3008254127-2026-00002
• Device Sequence Number: 10534064
• Product Code: HCF
• UDI-Device Identifier: 09349967000366
• UDI-Public: 09349967000366
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2026

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
• Operator of Device: Health Professional
• Device Model Number: RSG-14F
• Device Lot Number: 2516754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/12/2026; 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown