MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF71, 12X150 KII FIOS ADVFIX 6BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF71
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic hysterectomy.Event description: indication ended positively.No remains of the trocar in the abdomen.According to the user, this happened because the dissector got caught on the lower end of the trocar when it was removed.The damaged trocar was disposed of in the clinic after the operation.Intervention: fragment was retrieved.Patient status: indication ended positively.No remains of the trocar in the abdomen.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation, however a picture of the event unit was provided.Visual inspection confirmed that the cannula tip had fractured, as a fragment was missing.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any damages or non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.However, based on the description of the event, it is likely that the damaged cannula tip was caused by contact with an instrument during the procedure.
Event or Problem Description
Procedure performed: laparoscopic hysterectomy event description: indication ended positively.No remains of the trocar in the abdomen.According to the user, this happened because the dissector got caught on the lower end of the trocar when it was removed.The damaged trocar was disposed of in the clinic after the operation.Additional information received from applied medical representative via email on 12-aug-2021: the port was inserted during a laparoscopic procedure.The incident occurred while an instrument was being inserted through the port and the user bumped the port during insertion.Intervention: fragment was retrieved patient status: indication ended positively.No remains of the trocar in the abdomen.

• Brand Name: CFF71, 12X150 KII FIOS ADVFIX 6BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 12104301
• Report Number: 2027111-2021-00556
• Device Sequence Number: 17193363
• Product Code: GCJ
• UDI-Device Identifier: 00607915123031
• UDI-Public: (01)00607915123031(17)230901(30)01(10)1395242
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: CFF71
• Device Catalogue Number: 101470694
• Device Lot Number: 1395242
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/25/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DISSECTOR