MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFB73, 12X100 KII SH BLD ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFB73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2021
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: laparoscopic appendectomy.Event description: translation from complaint form: during the surgery the doctors realised plastic particles of the trocar in the abdomen of the patient.The particles have been collected and saved in a small preparation container.Additional information received from applied medical representative via email on 10-jan-2022: the trocar was inserted with the direct insertion technique.When the scope was inserted, after the balloon was inflated and upon checking the other trocar placements, the or staff discovered that the reflecting particles from beside the trocar balloon were stuck on the abdominal wall of the patient.After further checking for other particles in the abdomen and finding some, other trocars have been placed to collect the plastic particles.They were collected using a grasping forceps.The trocar has been removed and replaced with another one after checking for plastic residues.The or staff has examined the trocar obturator and cannula.The plastic pieces were found to have chipped off of the cannula between the cannula tip and the balloon.Type of intervention: retrieval of separated parts.Patient status: healthy, recovered and home.
Event or Problem Description
Procedure performed: laparoscopic appendectomy.Event description: translation from complaint form: during the surgery the doctors realised plastic particles of the trocar in the abdomen of the patient.The particles have been collected and saved in a small preparation container.Additional information received from applied medical representative via email on 10-jan-2022: the trocar was inserted with the direct insertion technique.When the scope was inserted, after the balloon was inflated and upon checking the other trocar placements, the or staff discovered that the reflecting particles from beside the trocar balloon were stuck on the abdominal wall of the patient.After further checking for other particles in the abdomen and finding some, other trocars have been placed to collect the plastic particles.They were collected using a grasping forceps.The trocar has been removed and replaced with another one after checking for plastic residues.The or staff has examined the trocar obturator and cannula.The plastic pieces were found to have chipped off of the cannula between the cannula tip and the balloon.Type of intervention: retrieval of separated parts.Patient status: healthy, recovered and home.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with four clear fragments.Visual inspection confirmed the complainant¿s experience of distal glue fragmentation.The clear fragments were identified to be a portion of the distal glue.Based on the condition of the returned unit, it is possible that the fragmentation was due to an object or instrument coming in contact with the distal glue.It is also possible that the glue was more susceptible to fragmentation.However, the exact root cause of the distal glue line fragmentation is unknown.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CFB73, 12X100 KII SH BLD 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: 13266806
• Report Number: 2027111-2022-00326
• Device Sequence Number: 4726310
• Product Code: GCJ
• UDI-Device Identifier: 00607915117634
• UDI-Public: (01)00607915117634(17)240908(30)01(10)1424775
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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: 09/08/2024
• Device Model Number: CFB73
• Device Catalogue Number: 101473808
• Device Lot Number: 1424775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• 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: 01/04/2022
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• 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