MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR33, 11X100 KII OPT ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFR33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: adrenalectomy event description: product: cfr33 "when the operation was about to be completed and the bleeding situation was checked, a green fragment was discovered in the abdomen, identified upon retrieval as a fragment of a trocar.An extensive search was made for another fragment, but it was not found.The patient's condition is currently stable; however, the doctor will continue to monitor it closely." additional information has been received on 03may2024 via email from distributor: "the patient stayed stable during their hospital stay, and there was no need to extend it because of this incident.The patient returned for a check-up on (b)(6) 2024, and everything was normal.Here is what happened during the procedure: as the surgery neared completion, during the surgeon's final check for any bleeding, fragments were discovered inside the abdominal cavity.The cause of the cfr33 rupture is unknown.The tip was where the fracture occurred.No robot was involved in the surgery, and c6001 was inside the cannula at the time of the incident." intervention: it was finished with the same instrument.Patient status: the patient stayed stable during their hospital stay, and there was no need to extend it because of this incident.The patient returned for a check-up on (b)(6) 2024, and everything was normal.
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 returned to applied medical for evaluation, along with a clear fragment.Visual inspection confirmed the complainant¿s experience of a cannula fracture.The clear fragment was identified to be part of the cannula tip.Based on the condition of the returned unit, it is possible that the fractured cannula was caused by force exerted on the cannula tip during the procedure.However, applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.
Event or Problem Description
Procedure performed: adrenalectomy.Event description: product: cfr33."when the operation was about to be completed and the bleeding situation was checked, a green fragment was discovered in the abdomen, identified upon retrieval as a fragment of a trocar.An extensive search was made for another fragment, but it was not found.The patient's condition is currently stable; however, the doctor will continue to monitor it closely." additional information has been received on 03may2024 via email from distributor: "the patient stayed stable during their hospital stay, and there was no need to extend it because of this incident.The patient returned for a check-up on (b)(6) 2024, and everything was normal.Here is what happened during the procedure: as the surgery neared completion, during the surgeon's final check for any bleeding, fragments were discovered inside the abdominal cavity.The cause of the cfr33 rupture is unknown.The tip was where the fracture occurred.No robot was involved in the surgery, and c6001 was inside the cannula at the time of the incident." intervention: it was finished with the same instrument.Patient status: the patient stayed stable during their hospital stay, and there was no need to extend it because of this incident.The patient returned for a check-up on (b)(6) 2024, and everything was normal.

• Brand Name: CFR33, 11X100 KII OPT ADVFIX 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: 19255426
• Report Number: 2027111-2024-00620
• Device Sequence Number: 7310087
• Product Code: GCJ
• UDI-Device Identifier: 00607915123222
• UDI-Public: (01)00607915123222(17)250627(30)01(10)1457583
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083638
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/27/2025
• Device Model Number: CFR33
• Device Catalogue Number: 101245801
• Device Lot Number: 1457583
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• 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
• Patient Sex: Unknown