MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB33, 11X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: lap chole.Event description: "the facility reported a piece of plastic stuck within the canula rendering the device unusable." product is available for return.Additional information received on 05apr2023 via email from applied medical representative: no injury occurred.Another ctb33 was used to complete the case.The color of the piece was blue.No pieces fell into the patient.Laparoscopic tower was being used at the time of the incident.No other instruments were used prior to the incident.Intervention: another ctb33 was used to complete the case.Patient status: no injury occurred.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear fragment inside the trocar.Visual inspection confirmed the complainant¿s experience of a broken cannula wing tab inside the cannula.Based on the condition of the returned unit, it is possible that the reported event occurred during manufacturing and/or handling process of the obturator.It is also possible that the obturator wing tab broke off from a different trocar device during customer handling.However, the exact timing of the broken cannula wing tab could not be determined.
Event or Problem Description
Procedure performed: lap chole.Event description: "the facility reported a piece of plastic stuck within the canula rendering the device unusable." product is available for return.Additional information received on 05apr2023 via email from applied medical representative: no injury occurred.Another ctb33 was used to complete the case.The color of the piece was blue.No pieces fell into the patient.Laparoscopic tower was being used at the time of the incident.No other instruments were used prior to the incident.Intervention: another ctb33 was used to complete the case.Patient status: no injury occurred.

• Brand Name: CTB33, 11X100 KII SH BLD 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: 16704189
• Report Number: 2027111-2023-00410
• Device Sequence Number: 19752001
• Product Code: GCJ
• UDI-Device Identifier: 00607915124250
• UDI-Public: (01)00607915124250(17)250628(30)01(10)1457270
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K072674
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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: 06/28/2025
• Device Model Number: CTB33
• Device Catalogue Number: 101219501
• Device Lot Number: 1457270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAPAROSCOPIC TOWER
• Patient Sex: Unknown