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	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: tep hernia.Event description: [translation]: the trocar does not hold and comes out of its orifice permanently, which ends up causing the patient to bleed.These trocars are used because there is a stock shortage on the trocars usually used in this service.Current condition of the patient: need for additional care for the patient, even if there were no consequences a posteriori actions taken in the healthcare facility for patient management: control of bleeding, intervention could be completed by keeping the same trocar.Additional information received by email from applied medical representative on (b)(6) 2022: the trocar did not fix the abdominal wall and was always going out.This perpetual move has created bleedings that have been cured during the intervention.However, the procedure has been completed with the same trocar.Patient status: no consequences.Additional information received by email from applied medical representative on (b)(6) 2022: the trocar has been fixed with suture and bleedings stopped by hemostasis.The procedure was a tep hernia.The patient is well.The trocar hasn¿t been conserved (no reason explained).Type of intervention: control of bleeding, intervention could be completed by keeping the same trocar.Bleedings stopped by hemostasis.Patient status: the patient is well.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.The probability and criticality of harm resulting from this event have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: tep hernia.Event description: [translation]: the trocar does not hold and comes out of its orifice permanently, which ends up causing the patient to bleed.These trocars are used because there is a stock shortage on the trocars usually used in this service.Current condition of the patient: need for additional care for the patient, even if there were no consequences a posteriori actions taken in the healthcare facility for patient management: control of bleeding, intervention could be completed by keeping the same trocar.Additional information received by email from applied medical representative on 17june22: the trocar did not fix the abdominal wall and was always going out.This perpetual move has created bleedings that have been cured during the intervention.However, the procedure has been completed with the same trocar.Patient status : no consequences.Additional information received by email from applied medical representative on 28june22: the trocar has been fixed with suture and bleedings stopped by hemostasis.The procedure was a tep hernia.The patient is well.The trocar hasn¿t been conserved (no reason explained).Type of intervention: control of bleeding, intervention could be completed by keeping the same trocar.Bleedings stopped by hemostasis patient status: the patient is well.

• 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: 14881394
• Report Number: 2027111-2022-00650
• Device Sequence Number: 20394541
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550(17)250223(30)01(10)1444779
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

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: 02/23/2025
• Device Model Number: CTF03
• Device Catalogue Number: 101472912
• Device Lot Number: 1444779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown