MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS12, 11X100 KII SLEEVE ADVFIX 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFS12
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit 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: [name] incoming inspection po# (b)(4).This is a complaint from [name].The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: april 21, 2021.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.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.Hairlike object in pouch - cfs12 lot# 1407319 (1 ea).Patient status: patient not involved.Type of intervention: na.
Event or Problem Description
Name of procedure being performed na (incoming inspection).Detailed description of event: [name] incoming inspection po# (b)(4).This is a complaint from [name].The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: april 21, 2021.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.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.Hairlike object in pouch - cfs12 lot# 1407319 (1 ea).Patient status: patient not involved.Type of intervention na.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of hair inside the sterile unopened pouch.Based on the condition of the returned unit and the description of the event, the hair originated from an operator during the manufacturing process.

• Brand Name: CFS12, 11X100 KII SLEEVE ADVFIX 12/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: 11996132
• Report Number: 2027111-2021-00524
• Device Sequence Number: 14503031
• Product Code: GCJ
• UDI-Device Identifier: 00607915119850
• UDI-Public: (01)00607915119850(17)240224(30)01(10)1407319
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: No Information
• Device Expiration Date: 02/24/2024
• Device Model Number: CFS12
• Device Catalogue Number: 101245401
• Device Lot Number: 1407319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1