MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF75, 12X75 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF75
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
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 investigation.
Event or Problem Description
Procedure performed: gastrectomy.Event description: this is a complaint from the market.Please refer to the complaint sheet for investigation.Report from the sales rep.The valve was dropped into the body during the procedure.The piece was recovered from the body cavity.The case was completed with the new one.Additional information from sales rep: the septum and shield were dropped when it was taken out of the body.Initial investigation report the event unit was returned to us and visually inspected.The septum and the shield were detached.No visual damage was found in ddb.The unit will be returned to amr for further evaluation.Intervention: the case was completed with the new one.Patient status: no patient injury.
Event or Problem Description
Procedure performed: gastrectomy.Event description: this is a complaint from the market.Please refer to the complaint sheet for investigation.Report from the sales rep: the valve was dropped into the body during the procedure.The piece was recovered from the body cavity.The case was completed with the new one.Additional information from sales rep: the septum and shield were dropped when it was taken out of the body.Initial investigation report: the event unit was returned to us and visually inspected.The septum and the shield were detached (pic.1).No visual damage was found in ddb.The unit will be returned to amr for further evaluation.Intervention: the case was completed with the new one.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the returned unit confirmed that the shield, an internal plastic component of the seal, had separated from the seal.Engineering also observed that a piece of the septum, an internal rubber component of the seal, had also separated from the seal.Based on the condition of the returned unit and the description of the event, 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.".

• Brand Name: CFF75, 12X75 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
• MDR Report Key: 11233393
• Report Number: 2027111-2021-00314
• Device Sequence Number: 4086207
• Product Code: GCJ
• UDI-Device Identifier: 00607915136659
• UDI-Public: (01)00607915136659(17)230811(30)01(10)1394281
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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: 08/11/2023
• Device Model Number: CFF75
• Device Catalogue Number: 101471079
• Device Lot Number: 1394281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1