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	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
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 the investigation.
Event or Problem Description
Procedure performed: unknown.Event description: "foreign material in the check valve"."report from the sales rep: the brawn foreign material was found in the check valve when inserted into the body and tried to inject the air.The same product opened the second time was dirty.The case was completed with the third one.Initial investigation report: the event unit was returned to us and visually inspected.We confirmed the brawn foreign material like a tissue in the air insufflation port (pic.1).The other foreign material was adhered on the surface of the seal component (pic.2).The unit will be returned to amr for further evaluation." intervention: the case was completed with the third one.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of a foreign substance on the device.Engineering observed the yellow-brown material on the seal, sleeve, insufflation port, and check valve of the event unit.Applied medical is unable to determine the exact root cause of the reported event based on the evaluation of the returned unit.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: event 1 of 2: 2027111 - 2021 - 00302; event 2 of 2: 2027111 - 2021 - 00301."foreign material in the check valve." "report from the sales rep: the brawn foreign material was found in the check valve when inserted into the body and tried to inject the air.The same product opened the second time was dirty.The case was completed with the third one.Initial investigation report the event unit was returned to us and visually inspected.We confirmed the brawn foreign material like a tissue in the air insufflation port (pic.1).The other foreign material was adhered on the surface of the seal component (pic.2).The unit will be returned to amr for further evaluation." intervention: the case was completed with the third one.Patient status: no patient injury.

• 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: 11125508
• Report Number: 2027111-2021-00302
• Device Sequence Number: 666942
• Product Code: GCJ
• UDI-Device Identifier: 00607915136659
• UDI-Public: (01)00607915136659(17)221226(30)01(10)1377723
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 12/26/2022
• Device Model Number: CFF75
• Device Catalogue Number: 101471079
• Device Lot Number: 1377723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1