MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF33, 11X100 KII FIOS ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF33
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: unknown event description: today a trocar made by applied medical 11x100mm first entry ref # (b)(4) lot# 1488458 expiration date 4-7-2026 was in patient.Dr.[name] inserted the cadiere forcep and a piece of the gasket broke off from inside the trocar.The piece was retrieved and trocar removed from pt, tagged and bagged and given to you to report.Product is available for return.Additional information received on 08aug2023 via email from applied account manager: all pieces were retrieved from the patient.The color of the piece was both black and clear.The clear shield and duckbill or septum was ripped/torn and the clear shield and double duckbill or septum fell out.It's hard to tell if it was the septum or the double duckbill from looking through the bag.By looking at the black broken piece inside the bag, it looks similar to the part of the duckbill.No internal seal components were removed or cut in order to inspect the damaged component.Type of intervention: the piece was retrieved and trocar removed from pt.Patient status: no patient injury occurred.
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: unknown event description: today a trocar made by applied medical 11x100mm first entry ref # ctf33 lot# 1488458 expiration date 4-7-2026 was in patient.Dr.[name] inserted the cadiere forcep and a piece of the gasket broke off from inside the trocar.The piece was retrieved and trocar removed from pt, tagged and bagged and given to you to report.Product is available for return.Additional information received on 08aug2023 via email from applied account manager: all pieces were retrieved from the patient.The color of the piece was both black and clear.The clear shield and duckbill or septum was ripped/torn and the clear shield and double duckbill or septum fell out.It's hard to tell if it was the septum or the double duckbill from looking through the bag.By looking at the black broken piece inside the bag, it looks similar to the part of the duckbill.No internal seal components were removed or cut in order to inspect the damaged component.Type of intervention: the piece was retrieved and trocar removed from pt.Patient status: no patient injury occurred.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a black fragment and a clear component.Visual inspection confirmed the complainant¿s experience of seal component separation.The black fragment matched the missing portion of the septum, an internal rubber component of the seal.The clear component was identified to be the shield, an internal plastic component of the seal.Based on the condition of the returned unit, it is likely that the fragmented septum and dislodged shield were caused by non-axial insertion or removal of asymmetrical instruments through the trocar.Applied medical¿s instructions for use (ifu) states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.".

• Brand Name: CTF33, 11X100 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 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17550909
• Report Number: 2027111-2023-00559
• Device Sequence Number: 6967573
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212(17)260407(30)01(10)1488458
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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: 04/07/2026
• Device Model Number: CTF33
• Device Catalogue Number: 101219301
• Device Lot Number: 1488458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CADIER 8 PORT FOR DAVINCI AND RAYTEK; CADIER FORCEP
• Patient Sex: Prefer Not To Disclose