MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF73, 12X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF73
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	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: gyn procedure.Detailed description of event: when opening, it was noticed that there is a hair/thread on the trocar in the packaging.Product can be collected.This morning we gave a trocar 12mm ref cff73 to the gynaecologist.Unfortunately, this revealed the following sight.We gave a second trocar of the same batch and everything was fine.Type of intervention: used a new trocar.Patient status: na - before use.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.The hair was not observed on the returned unit during the visual inspection; however, visual inspection of the photograph provided by the customer confirmed the presence of hair on the device.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.Based on photograph of the event unit, it is most likely that the hair originated from an operator during the manufacturing process.
Event or Problem Description
Name of procedure being performed: gyn procedure.Detailed description of event: when opening, it was noticed that there is a hair/thread on the trocar in the packaging (see attached photo).Product can be collected.This morning we gave a trocar 12mm ref cff73 to the gynaecologist.Unfortunately, this revealed the following sight.We gave a second trocar of the same batch and everything was fine.Type of intervention: used a new trocar.Patient status: na - before use.

• Brand Name: CFF73, 12X100 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
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19647661
• Report Number: 2027111-2024-00721
• Device Sequence Number: 6587282
• Product Code: GCJ
• UDI-Device Identifier: 00607915117658
• UDI-Public: (01)00607915117658(17)270208(30)01(10)1514284
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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 Model Number: CFF73
• Device Catalogue Number: 101477591
• Device Lot Number: 1514284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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