MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0Q19, KII 8X100 Z-THR OPT SYS 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0Q19
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: unknown.Event description: the rep was not present for the case.During the procedure the plastic flange/latch tab dislodged into the patient's abdomen.It appears that when inserting the butterfly needle, the latch tab dislodged.A grasper was then used through the trocar and that pushed the flange into the patient's abdomen.There was no patient injury and the patient is okay.Intervention: the latch tab was removed from the patient.Patient status: patient is okay.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any 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.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.
Event or Problem Description
Procedure performed: unknown.Event description: the rep was not present for the case.During the procedure the plastic flange/latch tab dislodged into the patient's abdomen.It appears that when inserting the butterfly needle, the latch tab dislodged.A grasper was then used through the trocar and that pushed the flange into the patient's abdomen.There was no patient injury and the patient is okay.Intervention: the latch tab was removed from the patient.Patient status: patient is okay.

• Brand Name: C0Q19, KII 8X100 Z-THR OPT SYS 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: 16632321
• Report Number: 2027111-2023-00402
• Device Sequence Number: 5577448
• Product Code: GCJ
• UDI-Device Identifier: 00607915115920
• UDI-Public: (01)00607915115920(17)251214(30)01(10)1473089
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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: 12/14/2025
• Device Model Number: C0Q19
• Device Catalogue Number: 101063001
• Device Lot Number: 1473089
• Was Device Available for Evaluation?: No
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GRASPERS, BUTTERFLY NEEDLE.
• Patient Sex: Unknown