MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS22, 12X100 KII SLEEVE ZTHR 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTS22
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	05/12/2022
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 investigation.
Event or Problem Description
Procedure performed: colectomy.Event description: in the colectomy they saw a piece of seal black one in the abdomen.The patient is ok.This happened in the middle of surgery.They have 1 entire box with the same lot and 8 pieces left same lot, they told me that they would like to replace the trocar with new ones.Additional information received by email from applied medical representative on (b)(6) 2022: the piece was retrieved from patient.The seal was double duckbill seal, they found the entire seal.There s no pic or seal.Patient status: no patient injury or illness occur associated with the complaint event.
Event or Problem Description
Procedure performed: colectomy.Event description: in the colectomy they saw a piece of seal black one in the abdomen.The patient is ok.This happened in the middle of surgery.They have 1 entire box with the same lot and 8 pieces left same lot, they told me that they would like to replace the trocar with new ones.Additional information received by email from applied medical representative on 18may22: the piece was retrieved from patient.The seal was double duckbill seal, they found the entire seal.There' s no pic or seal.Patient status: no patient injury or illness occur associated with the complaint event.
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 of duckbill dislodgement.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 failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CTS22, 12X100 KII SLEEVE ZTHR 12/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: 14501593
• Report Number: 2027111-2022-00611
• Device Sequence Number: 14753080
• Product Code: GCJ
• UDI-Device Identifier: 00607915123734
• UDI-Public: (01)00607915123734(17)250104(30)01(10)1439526
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 01/04/2025
• Device Model Number: CTS22
• Device Catalogue Number: 101472328
• Device Lot Number: 1439526
• 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: 05/12/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MARYLAND, JOHANNES ENDOBAG, STAPLER, THUNDERBEAT
• Patient Sex: Prefer Not To Disclose