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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic gastric sleeve.Event description: rep was not present for the case.During the procedure the cannula broke in half while in the patient's abdomen.A scope was inside the cannula at the time.The cannula broke in the middle of the shaft, there was no particulation.The trocar had been inserted optically.The surgeon stated that they believe the patient's anatomy might have contributed to the incident.There was no patient injury.The case was completed with an [non-applied medical] trocar.Product is available for return.Intervention: the case was completed with an [non-applied medical] trocar.Patient status: no patient injury.
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.
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.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.
Event or Problem Description
Procedure performed: laparoscopic gastric sleeve.Event description: rep was not present for the case.During the procedure the cannula broke in half while in the patient's abdomen.A scope was inside the cannula at the time.The cannula broke in the middle of the shaft, there was no particulation.The trocar had been inserted optically.The surgeon stated that they believe the patient's anatomy might have contributed to the incident.There was no patient injury.The case was completed with an [non-applied medical] trocar.Product is available for return.Intervention: the case was completed with an [non-applied medical] trocar.Patient status: no patient injury.

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15218484
• Report Number: 2027111-2022-00700
• Device Sequence Number: 17614158
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212(17)250525(30)01(10)1449728
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: 05/25/2025
• Device Model Number: CTF33
• Device Catalogue Number: 101219301
• Device Lot Number: 1449728
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• 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: SCOPE.
• Patient Sex: Unknown