MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF01, 5X150 KII FIOS ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF01
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic partial gastrectomy.Event description: complaint 1 of 3: (b)(4).Complaint 2 of 3: (b)(4).Complaint 3 of 3:(b)(4).Two trocars broke upon insertion.One trocar was inserted with difficulty.[translation] i am the new hus in the operating room, replacing [name].Unfortunately, i was a little late in reporting the event, but i wanted to let you know that we had difficulties with 2 of your ctf01 trocars.The events occurred on august 31, 2023 with dr.[name] during the same laparoscopic parietal gastrectomy.The problem raised was that the patient's wall was difficult to pass through and that on two occasions, 5 x 150 mm trocars were broken at insertion.A third trocar could be inserted with difficulty, but without breakage.Dr.[name] was then assisted by dr.[name] and the two mentioned to me that it had never happened to them before.I was wondering if this issue had been raised elsewhere? the incident did not have a direct impact on the patient.The lot number of the trocars was 1473094 (the same for both) and they were not retained for analysis.Product is not available for return.Additional information received on 31oct2023 via email from account manager: cannula of trocar broke."cannula cracked and affected direction that it was being inserted." there are no images of the trocars.The breaks were not considered to be clean breaks, they were cracked.No pieces fell into the patient.The trocars were inserted alternating clockwise and counterclockwise direction during insertion.The case was not robotic.Intervention: a third trocar could be inserted with difficulty, but without breakage.Patient status: recovered.
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be sent upon completion of the investigation.
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.
Event or Problem Description
Procedure performed: laparoscopic partial gastrectomy event description: complaint 1 of 3: (b)(4).Complaint 2 of 3: (b)(4).Complaint 3 of 3: (b)(4).Two trocars broke upon insertion.One trocar was inserted with difficulty.[translation].I am the new hus in the operating room, replacing [name].Unfortunately, i was a little late in reporting the event, but i wanted to let you know that we had difficulties with 2 of your ctf01 trocars.The events occurred on (b)(6) 2023 with dr.[name] during the same laparoscopic parietal gastrectomy.The problem raised was that the patient's wall was difficult to pass through and that on two occasions, 5 x 150 mm trocars were broken at insertion.A third trocar could be inserted with difficulty, but without breakage.Dr.[name] was then assisted by dr.[name] and the two mentioned to me that it had never happened to them before.I was wondering if this issue had been raised elsewhere? the incident did not have a direct impact on the patient.The lot number of the trocars was 1473094 (the same for both) and they were not retained for analysis.Product is not available for return.Additional information received on 31oct2023 via email from account manager: cannula of trocar broke."cannula cracked and affected direction that it was being inserted." there are no images of the trocars.The breaks were not considered to be clean breaks, they were cracked.No pieces fell into the patient.The trocars were inserted alternating clockwise and counterclockwise direction during insertion.The case was not robotic.Intervention: a third trocar could be inserted with difficulty, but without breakage.Patient status: recovered.

• Brand Name: CTF01, 5X150 KII FIOS ZTHR 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA ; CA
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 18145203
• Report Number: 2027111-2023-00745
• Device Sequence Number: 12516679
• Product Code: GCJ
• UDI-Device Identifier: 00607915124014
• UDI-Public: (01)00607915124014(17)251206(30)01(10)1473094
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/10/2024

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: 12/06/2025
• Device Model Number: CTF01
• Device Catalogue Number: 101412701
• Device Lot Number: 1473094
• Was Device Available for Evaluation?: No
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown