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	12/05/2022
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: laparoscopic anterior resection.Event description: how was the device being used/what action was being performed when the event occurred? inserting/removing laparoscopic instruments through port.Foreign body identified and removed under vision.No replacement required as procedure was finishing.No other products required.No problems identified at beginning of case - no gas leaking until the end of the case, when it was discovered that the seal was inside the patient.The seal was able to be retrieved from the patient.The port did not need to be replaced as it was the end of the case.Type of intervention: no requirement for replacement as procedure was finished.Patient status: no harm to patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the event unit confirmed the complainant¿s experience of seal leakage and seal component separation.The septum, an internal rubber component of the seal, was fragmented.Based on the condition of the returned unit, it is likely that the septum fragmentation was caused by non-axial insertion or removal of asymmetrical instruments through the trocar.Applied medical¿s instructions for use (ifu) states, "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." as the septum was fragmented, a tight seal could not be maintained, resulting in gas leakage from the seal.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as septum fragmentation is unlikely to cause or contribute to death or serious injury.
Event or Problem Description
Procedure performed: laparoscopic anterior resection.Event description: how was the device being used/what action was being performed when the event occurred? inserting/removing laparoscopic instruments through port foreign body identified and removed under vision.No replacement required as procedure was finishing.No other products required.No problems identified at beginning of case - no gas leaking until the end of the case, when it was discovered that the seal was inside the patient.The seal was able to be retrieved from the patient.The port did not need to be replaced as it was the end of the case.Type of intervention: no requirement for replacement as procedure was finished.Patient status: no harm to patient.

• 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: 15999823
• Report Number: 2027111-2022-00862
• Device Sequence Number: 12432079
• Product Code: GCJ
• UDI-Device Identifier: 00607915117634
• UDI-Public: (01)00607915117634(17)250203(30)01(10)1441177
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/21/2023

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: 02/03/2025
• Device Model Number: CFB73
• Device Catalogue Number: 101245901
• Device Lot Number: 1441177
• 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: 12/06/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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