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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic procedure.Event description: confirmed device was inserted using standard downward force with 10-2 twisting motion.Device snapped within first few seconds of insertion (only initial layer of skin pushed through).The surgeon subsequently used a replacement port of same product code with no issues.Patient was above average weight, no previous surgery.No changes in health resulting from the event.Device replaced with no issue.No additional intervention required intervention: the surgeon subsequently used a replacement port of same product code with no issues.Patient status: no issues.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic procedure.Event description: confirmed device was inserted using standard downward force with 10-2 twisting motion.Device snapped within first few seconds of insertion (only initial layer of skin pushed through).The surgeon subsequently used a replacement port of same product code with no issues.Patient was above average weight, no previous surgery.No changes in health resulting from the event.Device replaced with no issue.No additional intervention required intervention: the surgeon subsequently used a replacement port of same product code with no issues.Patient status: no issues.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a damaged trocar, both the cannula and obturator were bent.The wall thickness of the cannula and obturator were measured and met specifications.Based on the condition of the returned unit and similar previous incidents, it is likely that the reported event was caused by a high force exerted on the unit during insertion.It is possible that the physical characteristics of the patient contributed to the force exerted on the unit during insertion.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as a bent trocar is unlikely to cause or contribute to death or serious 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: 13286069
• Report Number: 2027111-2022-00329
• Device Sequence Number: 14630057
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550(17)240623(30)01(10)1419168
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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: 06/23/2024
• Device Model Number: CTF03
• Device Catalogue Number: 101138401
• Device Lot Number: 1419168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2022
• 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: 01/11/2022
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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