MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS02, 5X100 KII SLEEVE ADVFIX 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFS02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lap.Adnexectomy.Event description: during the operation, a puncture needle was inserted through the trocar and probably pushed the sealing cap purely into the abdominal cavity.There were no changes in health resulting from the event.They cut the seal in two pieces and removed it.Additional information received from applied medical representative via email 21mar2023: the customer retrieved all the pieces from the patient.Prior to the incident, they used a grasping forceps.Intervention: they cut the seal in two pieces and removed it.Patient status: is ok.
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: lap.Adnexectomy.Event description: during the operation, a puncture needle was inserted through the trocar and probably pushed the sealing cap purely into the abdominal cavity.There were no changes in health resulting from the event.They cut the seal in two pieces and removed it.Additional information received from applied medical representative via email 21mar23: the customer retrieved all the pieces from the patient.Prior to the incident, they used a grasping forceps.Intervention: they cut the seal in two pieces and removed it.Patient status: is ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, with a clear component.Visual inspection confirmed the complainant¿s experience of a dislodged shield.The clear component was identified to be the shield, an internal plastic component of the seal.Based on the condition of the returned unit, it is likely that the dislodged shield was caused by non-axial insertion of an asymmetrical instrument through the trocar.Applied medical¿s instructions for use (ifu) states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.".

• Brand Name: CFS02, 5X100 KII SLEEVE ADVFIX 12/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: 16605852
• Report Number: 2027111-2023-00396
• Device Sequence Number: 20018249
• Product Code: GCJ
• UDI-Device Identifier: 00607915117733
• UDI-Public: (01)00607915117733(17)250818(30)01(10)1464234
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: 08/18/2025
• Device Model Number: CFS02
• Device Catalogue Number: 101472915
• Device Lot Number: 1464234
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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: PUNCTURE NEEDLE, GRASPING FORCEPS
• Patient Sex: Unknown