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

Model Number	CB030
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
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 upon completion of the investigation.
Event or Problem Description
Procedure performed: inguinal hernia event description: fire and smoke came out of the scissor.Dr [name redacted] took another cb030 and finished the procedure without any problem.Information received from applied medical representative via email (b)(6), 2023: by fire, it means sparks at the first activation and immediately stopped using it.The smoke originated from the shaft.The sparks/smoke did not cause damage to tissue.There were no other instruments in the surgical field when the event occurred.3 meter cable of [brand name redacted] was being used to connect the scissors to the monopolar generator.Smoke happened after cautery action.Information received from applied medical representative via email (b)(6) 2023: no damage noticed to the insulation.The sparks occurred between middle and proximal end of the shaft.The sparks did not come into contact with any non-target tissue.Patient status: no patient injury.Intervention: device replacement.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Functional testing was performed on the event unit.However, the complainant¿s experience could not be confirmed as the unit passed all relevant testing.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.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: inguinal hernia.Event description: fire and smoke came out of the scissor.Dr [name redacted] took another cb030 and finished the procedure without any problem.Information received from applied medical representative via email 29jun23: by fire, it means sparks at the first activation and immediately stopped using it.The smoke originated from the shaft.The sparks/smoke did not cause damage to tissue.There were no other instruments in the surgical field when the event occurred.3 meter cable of [brand name redacted] was being used to connect the scissors to the monopolar generator.Smoke happened after cautery action.Information received from applied medical representative via email 30jun23: no damage noticed to the insulation.The sparks occurred between middle and proximal end of the shaft.The sparks did not come into contact with any non-target tissue.Patient status: no patient injury.Intervention: device replacement.

• Brand Name: CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (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: 17308910
• Report Number: 2027111-2023-00514
• Device Sequence Number: 15112833
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)251229(30)01(10)1475221
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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: 12/29/2025
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1475221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONOPOLAR GENERATOR; WOLF CABLE
• Patient Sex: Unknown