MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF05, 5X75 KII FIOS ADV FIX 6/BX; GCJ

Model Number	CFF05
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event units returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: na (incoming inspection).Detailed description of event: this is a complaint from aomori olympus evaluation team.The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: august 9 2018.We found defects as the result of incoming inspection of the products.We found the defects that already informed applied medical by cer.We just inform you the defect and return the products for following defects.You do not need investigation.Products for following defects.You do not need investigation.Pouch torn - cer (b)(4); scratch on pouch - cer (b)(4); tip deformed - cer (b)(4).Concomitant device: na.Patient status: na.
Additional Manufacturer Narrative
This is a follow up report for mdr report# 2027111-2019-00327.A follow-up report will be provided upon completion of the evaluation.
Event or Problem Description
Name of procedure being performed: na (incoming inspection).Detailed description of event: this is a complaint from aomori olympus evaluation team.The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: august 9 2018.We found defects as the result of incoming inspection of the products.We found the defects that already informed applied medical by cer.We just inform you the defect and return the products for following defects.You do not need investigation.Products for following defects.You do not need investigation.Pouch torn: (b)(4).Scratch on pouch: (b)(4).Tip deformed: (b)(4).Concomitant device: na.Patient status: na.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that there was a hole in the c-film of the pouch.Based on the condition of the returned unit, the reported event was caused by a foreign material getting caught in the pouching equipment during the pouching process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible process enhancements intended to further minimize the potential for this type of event to occur.Applied has issued a recall and has assigned it reference number 2027111-01/16/19-001-r.
Event or Problem Description
Name of procedure being performed: na (incoming inspection) detailed description of event: this is a complaint from aomori olympus evaluation team.The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: august 9 2018.Please refer to the attachment file.We found defects as the result of incoming inspection of the products.Please refer to the attachment material for the quantity which returns the products.I) we found the defects that already informed applied medical by cer.We just inform you the defect and return the products for following defects.You do not need investigation.Products for following defects.You do not need investigation.(1) pouch torn - cer 2018-101148 (2) scratch on pouch - cer 2018-101152 (3) tip deformed - cer 2018-101147.Concomitant device: na.Patient status: na.

• Brand Name: CFF05, 5X75 KII FIOS ADV FIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida emprsa; rancho santa margarita CA 92688
• MDR Report Key: 8269453
• Report Number: 2027111-2019-00327
• Device Sequence Number: 19363088
• Product Code: GCJ
• UDI-Device Identifier: 00607915123123
• UDI-Public: (01)00607915123123(17)210715(30)01(10)1330981
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2019

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: No Information
• Device Expiration Date: 07/15/2021
• Device Model Number: CFF05
• Device Catalogue Number: 101220801
• Device Lot Number: 1330981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/16/2019; 01/16/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 01/24/2019; 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1