MAUDE Adverse Event Report: THE O R COMPANY PTY LTD SUTURE PASSOR PRO; INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Model Number	RSG-14F
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
At the end of the procedure when the surgery team was attempting to use the carter thompson closure device laparoscopically, 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.This resulted in one piece being left inside the patient, which is not supposed to happen.Both pieces of device were immediately removed from patient and inspected.All parts of the device appeared fully intact.Although there was low suspicion of any additional pieces of device being broken off or left inside the patient, an x-ray was requested by rn at the end of the procedure to verify this.Radiologist confirmed no foreign bodies retained with exception of endo clips x4 used during procedure.

• Brand Name: SUTURE PASSOR PRO
• Common Device Name: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): THE O R COMPANY PTY LTD; 6945 southbelt dr. s.e.; caledonia MI 49316
• MDR Report Key: 25716105
• Report Number: 25716105
• Device Sequence Number: 10597799
• Product Code: HCF
• UDI-Device Identifier: 09349967000366
• UDI-Public: (01)09349967000366
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2026
• Report Date (Section F): 07/01/2026

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 the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2026
• 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 Sex: Unknown
• Date Report Sent to FDA: 07/01/2026