MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFB73, 12X100 KII SH BLD ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFB73
Medical Device Problem Codes	Material Fragmentation (1261); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: unknown event description: [translation] i would like to point out to you a problem of materiovigilance observed on a trocard sleeve (ref cfb73 lot 1424774).The sleeve was defective, the balloon was punctured, we kept the product (it was in contact with the patient but was decontaminated).From the form: the balloon was pierced and the surgeon was not able to inflate it.Patient status: no patient injury or illness occurred 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 possible that the cannula tip fractured due a large force applied to the cannula 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.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: unknown.Event description: [translation] i would like to point out to you a problem of materiovigilance observed on a trocard sleeve (ref cfb73 lot 1424774).The sleeve was defective, the balloon was punctured, we kept the product (it was in contact with the patient but was decontaminated).From the form: the balloon was pierced and the surgeon was not able to inflate it.Additional information received by email from applied medical representative on 25oct21: there was visible damage to the balloon.There was scratches on the shaft of the trocar.Metal retractors were used.Farabeuf retractor (for the open coeliochirugie technique).No sharp instrumentation come in contact with the balloon.The teams used a cfb73 trocar to perform open laparoscopic surgery.The surgeon placed the trocar.They inflated the fixation balloon and then pulled the trocar up.The trocar came straight out of the body: at this moment, they noticed that the fixation balloon was pierced (and not inflated correctly) and the distal part of the trocar was damaged.The nurse checked in the primary packaging of the trocar: no debris present.No patient injury: the surgeon also checked that no trocar debris was present in the patient's body.I have no other information.Intervention: the surgeon also checked that no trocar debris was present in the patient's body patient status: no patient injury: the surgeon also checked that no trocar debris was present in the patient's body.

• Brand Name: CFB73, 12X100 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: 12674076
• Report Number: 2027111-2021-00686
• Device Sequence Number: 11894661
• Product Code: GCJ
• UDI-Device Identifier: 00607915117634
• UDI-Public: (01)00607915117634(17)240812(30)01(10)1424774
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: 08/12/2024
• Device Model Number: CFB73
• Device Catalogue Number: 101473808
• Device Lot Number: 1424774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• 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: 10/15/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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: FARABEUF RETRACTOR
• Patient Sex: Prefer Not To Disclose