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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
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: hepatectomy.Event description: when grasper insert this device through the septum is not smoothly.Surgeon open the seal house and check, then they find the valve was coming off.They replaced with a new one to completed this surgery.Product available for return.Additional information was received via email on 07oct2021 from the distributor: a 5mm grasper was used with the trocar.No other instrumentation was used prior to the incident.No internal seal components were removed or cut in order to inspect the damaged component.The valve did detach.Type of intervention: the case was completed with a new one.Patient status: fine.
Event or Problem Description
Procedure performed: hepatectomy.Event description: when grasper insert this device through the septum is not smoothly.Surgeon open the seal house and check, then they find the valve was coming off.They replaced with a new one to completed this surgery.Product available for return.Additional information was received via email on 07oct2021 from the distributor: a 5mm grasper was used with the trocar.No other instrumentation was used prior to the incident.No internal seal components were removed or cut in order to inspect the damaged component.The valve did detach.Type of intervention: the case was completed with a new one.Patient status: fine.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a black fragment.Visual inspection of the event unit confirmed that the shield, an internal plastic component of the seal, had separated from the seal.The black fragment matched the missing portion of the septum, an internal rubber component of the seal.Based on the condition of the returned unit, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instruments 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." correction: removed "company representative" from g2 report source.

• 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: 12632417
• Report Number: 2027111-2021-00667
• Device Sequence Number: 4344206
• Product Code: GCJ
• UDI-Device Identifier: 00607915117634
• UDI-Public: (01)00607915117634(17)240204(30)01(10)1407318
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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: 02/04/2024
• Device Model Number: CFB73
• Device Catalogue Number: 101245901
• Device Lot Number: 1407318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• 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: GRASPER.; GRASPER
• Patient Sex: Unknown