MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR03, 5X100 KII OPT ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFR03
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	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a follow-up report to medwatch (b)(4).The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: laparoscopic, repair of anterior abdominal hernia (epigastric, incisional, ventral, umbilical, spigelian), laparoscopic, intal, inc implntn of mesh when perf, tot len of def; 3 cm incarc or strang.Detailed description of event: complaint created based off medwatch report.Uf/importer report (b)(4), hair found on the trocar during sterile field setup.Product is available for return.Patient status: (no patient involvement).Type of intervention: the defect was identified prior to the start of the case, and the item was removed.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of hair.Based on the condition of the returned unit and the description of the event, it is likely that the hair originated from an operator and was packaged with the product during the manufacturing process.This report is to follow-up medwatch #(b)(4).
Event or Problem Description
Name of procedure being performed: laparoscopic, repair of anterior abdominal hernia (epigastric, incisional, ventral, umbilical, spigelian), laparoscopic, intal, inc implntn of mesh when perf, tot len of def; < 3 cm; incarc or strang detailed description of event: complaint created based off medwatch report.Uf/importer report # (b)(4).Hair found on the trocar during sterile field setup.Product is available for return.Patient stauts: ni (no patient involvement).Type of intervention: the defect was identified prior to the start of the case and the item was removed.

• Brand Name: CFR03, 5X100 KII OPT 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: 16825412
• Report Number: 2027111-2023-00428
• Device Sequence Number: 20586755
• Product Code: GCJ
• UDI-Device Identifier: 00607915119881
• UDI-Public: (01)00607915119881(17)251024(30)01(10)1468370
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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: 10/24/2025
• Device Model Number: CFR03
• Device Catalogue Number: 101221201
• Device Lot Number: 1468370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown