MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF35, 11X100 KII FIOS Z-THREAD DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF35
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lap hysterectomy.Event description: translation during surgery at 8/12, a trocar 11x100 kii fios dual pack from applied (ref: ctf35) was noted to have a defect.The tip of the trocar pin has an abnormal shape, so it could not be used in the procedure.The tip of the pin appears "melted" intervention: another trocar.Patient status: n/a.
Additional Manufacturer Narrative
The event unit has returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: lap hysterectomy.Event description: [translation] during surgery at at 8/12, a trocar 11x100 kii fios dual pack from applied (ref: ctf35) was noted to have a defect.The tip of the trocar pin has an abnormal shape, so it could not be used in the procedure.The tip of the pin appears "melted" intervention: device replaced.Patient status: n/a.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.The complainant¿s experience of a melted obturator tip could not be confirmed as the tip was fractured.Based on the condition of the returned unit, it is likely that the obturator tip fractured due to the obturator material being susceptible to fracture.Based upon the description of the event, the event was not reportable as a melted obturator tip is unlikely to lead to death or serious injury.However, based on the evaluation of the returned unit, applied medical determined that this event is reportable as a fractured obturator tip is likely to lead to death or serious injury.

• Brand Name: CTF35, 11X100 KII FIOS Z-THREAD DP 10/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16330402
• Report Number: 2027111-2023-00338
• Device Sequence Number: 6419980
• Product Code: GCJ
• UDI-Device Identifier: 00607915129880
• UDI-Public: (01)00607915129880(17)250502(30)01(10)1449727
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2025
• Device Model Number: CTF35
• Device Catalogue Number: 101473278
• Device Lot Number: 1449727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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