MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF03, 5X100 KII FIOS Z-THR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a damaged obturator tip as the tip was fractured.Based on the condition of the returned unit, it is possible that the obturator tip fracture was caused by prolonged lipid exposure while the unit was in transit back to applied medical.It is also possible that the obturator tip fracture was caused by the obturator material being more susceptible to fracture.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Based upon the initial description of the event, a bent obturator tip is not considered to be reportable as it is unlikely to cause or contribute to death or serious injury.However, the event is considered reportable due to the fractured obturator tip that was observed during the evaluation of the returned unit.
Event or Problem Description
Procedure performed: unk event description: limited information is available at the time of report.Additional information was received via telephone on 19dec2022 from applied medical representative: tip of obturator bent going into incision.Product available for return.Patient status: no patient injury.

• Brand Name: CTF03, 5X100 KII FIOS Z-THR 6/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: 16541742
• Report Number: 2027111-2023-00376
• Device Sequence Number: 12593893
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550(17)250912(30)01(10)1461376
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2025
• Device Model Number: CTF03
• Device Catalogue Number: 101138401
• Device Lot Number: 1461376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• 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