MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS02, 5X100 KII SLEEVE ADVFIX 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFS02
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2021
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: endoscopic umbilical hernia repair.Event description: the dr performed a endo umbilical hernia repair.Apparently after deflating the trocar when the procedure was complete, and they took the sleeve out of the patient the tip of the trocar broke off and the balloon disintegrated.According to the scrub sister, they think that during the procedure maybe the diathermy touched the sleeve.Type of intervention: fragments were retrieved patient status: the procedure time was prolonged with 1 hour because they had to take the balloon fragments and plastic of the sleeve out of the abdomen of the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a damaged cannula tip and balloon.The cannula tip was fractured and appeared to be melted along with the balloon.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by a heat-producing instrument used during the procedure, that came in close contact with the cannula tip.The heat likely soften the cannula and balloon material, making it more susceptible to damage when forces were exerted on the unit during removal.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: endoscopic umbilical hernia repair event description: the dr performed a endo umbilical hernia repair.Apparently after deflating the trocar when the procedure was complete, and they took the sleeve out of the patient the tip of the trocar broke off and the balloon disintegrated.According to the scrub sister, they think that during the procedure maybe the diathermy touched the sleeve.Type of intervention: fragments were retrieved patient status: the procedure time was prolonged with 1 hour because they had to take the balloon fragments and plastic of the sleeve out of the abdomen of the patient.

• Brand Name: CFS02, 5X100 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12749095
• Report Number: 2027111-2021-00705
• Device Sequence Number: 20046623
• Product Code: GCJ
• UDI-Device Identifier: 00607915117733
• UDI-Public: (01)00607915117733(17)240815(30)01(10)1420387
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

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: 08/15/2024
• Device Model Number: CFS02
• Device Catalogue Number: 101472915
• Device Lot Number: 1420387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DIATHERMY
• Patient Sex: Unknown