MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX; LAPROSCOPE, GYNECOLOGICAL (AND ACCESSORIES)

Model Number	CB030
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.
Event or Problem Description
Procedure performed: robotic hernia repair.Event description: the surgeon was using the scissors with monopolar energy.The device did not work when they pressed the pedal.They removed the scissors from the monopolar cord and unplugged the device.A metal piece came out in the area that connects the cord and scissors around the handle.The case was completed with the new device.No patient injury.Product is available for return.Patient status: no patient injury.Intervention: the case was completed with the new device.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection observed that the banana plug was detached.Testing was performed on the event unit which confirmed the complainant¿s experience as the monopolar function did not work.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by banana plug not being attached properly during manufacturing.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: robotic hernia repair.Event description: the surgeon was using the scissors with monopolar energy.The device did not work when they pressed the pedal.They removed the scissors from the monopolar cord and unplugged the device.A metal piece came out in the area that connects the cord and scissors around the handle.The case was completed with the new device.No patient injury.Product is available for return.Additional information was received via email on 14aug2023 from [name], account manager i, applied medical "the device¿s lot number is 1485379." patient status: no patient injury.Intervention: the case was completed with the new device.

• Brand Name: CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX
• Common Device Name: LAPROSCOPE, GYNECOLOGICAL (AND ACCESSORIES)
• 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: 17425986
• Report Number: 2027111-2023-00540
• Device Sequence Number: 5955598
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)260314(30)01(10)1485379
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K062169
• 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): 01/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2026
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1485379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown