MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFB33, 11X100 KII SH BLD ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFB33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2022
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: unknown.Event description: [translation] the service declares that: while taking out the surgical piece through the sleeve of this trocar, and putting back this sleeve in the incision, the surgeon noticed that a piece was missing, the surgeon checked the whole abdominal cavity and cleaned it with 3l of physiological serum.Additional information from product complaint form received on 06dec2022: during specimen retrievement through the canula a piece of canula broke.Type of intervention: the surgeon checked the whole abdominal cavity and cleaned it with 3l of physiological serum.Patient status: ok.
Event or Problem Description
Procedure performed: exploratory laparoscopy event description: [translation] the service declares that: while taking out the surgical piece through the sleeve of this trocar, and putting back this sleeve in the incision, the surgeon noticed that a piece was missing, the surgeon checked the whole abdominal cavity and cleaned it with 3l of physiological serum.Additional information from product complaint form received on 06dec22 via email: during specimen retrievement through the canula a piece of canula broke additional information received from applied medical representative via email on 19jan23: [translation] the procedure was an exploratory laparoscopy.There was no difficulty in placing the trocar.The procedure was as described in the osiris.In spite of a thorough washing, the fragment was not found.Type of intervention: the surgeon checked the whole abdominal cavity and cleaned it with 3l of physiological serum.Patient status: ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a broken cannula tip.Based on the condition of the returned unit, it is possible that the broken cannula tip was due to an object or instrument coming in contact with the cannula tip and/or excess force exerted on the cannula tip.It is also possible that the cannula material was more susceptible to breakage.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CFB33, 11X100 KII SH BLD ADVFIX 6/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: 15982810
• Report Number: 2027111-2022-00858
• Device Sequence Number: 12502613
• Product Code: GCJ
• UDI-Device Identifier: 00607915119843
• UDI-Public: (01)00607915119843(17)250810(30)01(10)1456111
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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: 08/10/2025
• Device Model Number: CFB33
• Device Catalogue Number: 101473821
• Device Lot Number: 1456111
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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
• Patient Sex: Unknown