MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS12, 11X100 KII SLEEVE ADVFIX 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFS12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
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: laparoscopic radical prostatectomy.Event description: [translation] during the procedure the distal part of the cannula has broken after a contact with the laparoscopic instrument.The pieces of plastic in abdomen have been partially recovered.The customer will retain the cannula for any investigation.Type of intervention: the pieces of plastic in abdomen have been partially recovered.Patient status: no patient injury or illness occur associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula tip.Based on the condition of the returned unit, it is likely that the cannula fractured due to excessive force exerted on the tip.It is also possible that the cannula was more susceptible to breakage.However, the exact root cause of the cannula tip fracture is unknown.
Event or Problem Description
Procedure performed: laparoscopic radical prostatectomy.Event description: [translation] during the procedure the distal part of the cannula has broken after a contact with the laparocopic instrument.The pieces of plastic in abdomen have been partially recovered.The customer will retain the cannula for any investigation.Type of intervention: the pieces of plastic in abdomen have been partially recovered.Patient status: no patient injury or illness occur associated with the complaint event.

• Brand Name: CFS12, 11X100 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
• MDR Report Key: 11798474
• Report Number: 2027111-2021-00484
• Device Sequence Number: 3847172
• Product Code: GCJ
• UDI-Device Identifier: 00607915119850
• UDI-Public: (01)00607915119850(17)240105(30)01(10)1405882
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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: 01/05/2024
• Device Model Number: CFS12
• Device Catalogue Number: 101472329
• Device Lot Number: 1405882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAPAROCOPIC INSTRUMENT