MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFB12, 5X100 KII SH BLD ADVFIX DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CFB12

Device Problems Retraction Problem (1536); Fail-Safe Did Not Operate (4046)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2023

Event Type  malfunction  

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 Description

Event date is unknown.Procedure performed: unknown.Event description: [translation] we have experienced an incident with a laparoscopic trocar (ref: cfb12, lot: 1464276) whose blade did not retract at the time of the test before the trocar was inserted.The device was kept for expertise, if needed.Patient status: no patient injury has been reported.

Event Description

Procedure performed: exploratory laparoscopy.Event description: [translation] we have experienced an incident with a laparoscopic trocar (ref: (b)(4), lot: 1464276) whose blade did not retract at the time of the test before the trocar was inserted.The device was kept for expertise, if needed.Additional information received by applied medical representative on 15feb23 via email: it can be confirmed that there was no problem with the patient, as the device was not used.It was the nurse who reportedly said the device was not working.Additional information received by applied medical representative on 3mar23 via email: [translation] the surgeon can't remember if the red indicator/blade remain exposed after insertion and the device has already been returned patient status: no problem with the patient.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection noted that an internal component, the switch arm, was damaged.Functional testing could not confirm the complainant¿s experience of the blade not retracting as the blade could not be armed.Based on the condition of the returned unit, the damaged switch arm prevented the blade from being armed.As the blade could not be armed, the red indicator and the blade could not be exposed.The damaged switch arm component was likely a result of operator error during manufacturing.This event was initially reported based on the description of a blade retraction failure received during complaint intake.However, based on evaluation of the returned unit, applied medical determined that this event is not reportable as the blade of the device could not be armed as a result of the damaged switch arm component.As the blade could not be exposed, the unit was non-functional and would likely be replaced.Thus, this event is unlikely to lead to death or serious injury.

• Brand Name: CFB12, 5X100 KII SH BLD ADVFIX DP 10/BX
• Type of Device: 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: 16380346
• MDR Text Key: 309608718
• Report Number: 2027111-2023-00344
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915124106
• UDI-Public: (01)00607915124106(17)250831(30)01(10)1464276
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K083638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CFB12
• Device Catalogue Number: 101473834
• Device Lot Number: 1464276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1