MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF03, 5X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF33
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	01/17/2022
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 drainage of cyst.Event description: [surgeon name] - aspirating needle used to drain cyst.Resistance felt by [surgeon name] whilst atempting to insert needle through trocar.She then tried to push harder to overcome the resistance which meant that part of seal housing came through into the abdomen.This information was taken from [thearte co-ordinator name] who claimed that this fault may be from user error.The broken part of the seal housing was pulled back out through a trocar and caused no harm to the patient who was discharged from the hospital and has suffered no ill effects.[thearte co-ordinator name] has completed a datex incident report as part of their internal procedures.Type of intervention: component retrieved.Patient status: patient is home and well, unaffected by the event.
Event or Problem Description
Procedure performed: laparoscopic drainage of cyst event description: [surgeon name] - aspirating needle used to drain cyst.Resistance felt by [surgeon name] whilst attempting to insert needle through trocar.She then tried to push harder to overcome the resistance which meant that part of seal housing came through into the abdomen.This information was taken from [theatre co-ordinator name] who claimed that this fault may be from user error.The broken part of the seal housing was pulled back out through a trocar and caused no harm to the patient who was discharged from the hospital and has suffered no ill effects.[theatre co-ordinator name] has completed a datex incident report as part of their internal procedures.Type of intervention: component retrieved patient status: patient is home and well, unaffected by the event.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided.Visual inspection of the photo confirmed that the shield, an internal plastic component of the seal, had separated from the seal.Based on the description of the event and image provided, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instruments (aspiration needle) 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.".

• Brand Name: CFF03, 5X100 KII FIOS 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: 13386519
• Report Number: 2027111-2022-00344
• Device Sequence Number: 17367865
• Product Code: GCJ
• UDI-Device Identifier: 00607915117641
• UDI-Public: (01)00607915117641(17)240408(30)01(10)1412451
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/25/2022

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: 04/08/2024
• Device Model Number: CFF33
• Device Catalogue Number: 101473818
• Device Lot Number: 1412451
• Was Device Available for Evaluation?: No
• 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: 01/18/2022
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRATING NEEDLE-UNKNOWN MANUFACTURER
• Patient Sex: Unknown