MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR73, 12X100 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR73
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	12/20/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: partial nephrectomy event description: the [competitor device] manual stapler seemed to be getting stuck in the 12mm trocar, and it ended up pulling the entire trocar out when he removed the stapler.On the back table they were inserting the stapler into the trocar to test it and noticed it was getting caught on something and took a video to document it.They continued to test it and then the clear seal inside the trocar popped out.They sent me the video, pictures, and the official complaint document they filled out for this instance which includes the type of stapler and load they were using.Additional information was received via email on 12jan2024 from applied medical representative: there was no patient injury and the patient is doing "good".The case was completed with a [competitor device] 12mm trocar.The product is not available for return as it was thrown away after the case.Intervention: opened a [competitor device] 12mm trocar to complete the case.Patient status: good.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided, confirming the complainant¿s experience of shield dislodgment.The clear component was identified to be a shield, an internal plastic component of the seal.Based on the photograph of the event unit and the description of the event, it is likely that the dislodged shield was caused by the partially opened stapler jaws when it was inserted or removed through the trocar.
Event or Problem Description
Procedure performed: partial nephrectomy event description: the [competitor device] manual stapler seemed to be getting stuck in the 12mm trocar, and it ended up pulling the entire trocar out when he removed the stapler.On the back table they were inserting the stapler into the trocar to test it and noticed it was getting caught on something and took a video to document it.They continued to test it and then the clear seal inside the trocar popped out.They sent me the video, pictures, and the official complaint document they filled out for this instance which includes the type of stapler and load they were using.Additional information was received via email on 12jan2024 from applied medical representative: there was no patient injury and the patient is doing "good".The case was completed with a [competitor device] 12mm trocar.The product is not available for return as it was thrown away after the case.Intervention: opened a [competitor device] 12mm trocar to complete the case.Patient status: good.

• Brand Name: CTR73, 12X100 KII OPT 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: 18616920
• Report Number: 2027111-2024-00367
• Device Sequence Number: 19434545
• Product Code: GCJ
• UDI-Device Identifier: 00607915123680
• UDI-Public: (01)00607915123680(17)261010(30)01(10)1506561
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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 Model Number: CTR73
• Device Catalogue Number: 101219401
• Device Lot Number: 1506561
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC STAPLER WITH LOAD AND CARTRIDGE
• Patient Sex: Unknown