MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR12, 5X100 KII OPT ZTHR DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR12
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	05/04/2023
Type of Reportable Event	Malfunction
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: laparoscopic cholecystectomy.Event description: during a difficult laparoscopic cholecystectomy, amidst multiple instrument exchange, one of the valves detached from the port and fell into the abdominal cavity, it was the transparent plastic part that sits on top of the black double duckbill.The surgeon in question was a [name redacted] who completed the procedure with another trocar.The theatre co-ordinator, [name redacted] has kept the port in question and it is available to be sent to you.Information received from applied medical representative via email (b)(6) 2023: surgery completed and patient transferred to recovery area.All parts were retrieved from the patient.Clear seal valve came off not the entire component of the port.One side of the valve appears torn off.At time of the accident, laparoscopic fenestrated grasper was being used.Prior to the accident, fenestrated grasper was used.Internal seal components were not removed or cut in order to inspect the damaged component.Surgeon completed the procedure with another 5 mm port, ctf03.Type of intervention: procedure completed with other trocar (ctf03).Patient status: no patient injury - surgery completed and patient transferred to recovery area.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear component.Visual inspection confirmed the complainant¿s experience of a dislodged shield.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 dislodged shield was caused by non-axial insertion of an asymmetrical instrument 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.".
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: during a difficult laparoscopic cholecystectomy, amidst multiple instrument exchange, one of the valves detached from the port and fell into the abdominal cavity, it was the transparent plastic part that sits on top of the black double duckbill.The surgeon in question was a [name redacted] who completed the procedure with another trocar.The theatre co-ordinator, [name redacted] has kept the port in question and it is available to be sent to you.Information received from applied medical representative via email 5may23: surgery completed and patient transferred to recovery area.All parts were retrieved from the patient.Clear seal valve came off not the entire component of the port.One side of the valve appears torn off.At time of the accident, laparoscopic fenestrated grasper was being used.Prior to the accident, fenestrated grasper was used.Internal seal components were not removed or cut in order to inspect the damaged component.Surgeon completed the procedure with another 5 mm port, ctf03.Type of intervention: procedure completed with other trocar (ctf03).Patient status: no patient injury - surgery completed and patient transferred to recovery area.

• Brand Name: CTR12, 5X100 KII OPT ZTHR DP 10/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: 16892416
• Report Number: 2027111-2023-00443
• Device Sequence Number: 6162710
• Product Code: GCJ
• UDI-Device Identifier: 00607915123505
• UDI-Public: (01)00607915123505(17)250913(30)01(10)1460792
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060096
• 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): 07/24/2023

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: 09/13/2025
• Device Model Number: CTR12
• Device Catalogue Number: 101094501
• Device Lot Number: 1460792
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LAPAROSCOPIC FENESTRATED GRASPER
• Patient Sex: Unknown