MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0Q19, KII 8X100 Z-THR OPT SYS 6/BX; GCJ

Model Number	C0Q19
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation along with the shield, a clear plastic internal component of the seal.Visual inspection of the event unit confirmed the complainant's experience of seal component separation.The petals of the shield were torn and bent with scratches.Based on the condition of the returned unit and the description of the event, it is likely that the dislodged shield was caused by non-axial insertion or removal of asymmetrical instrumentation through the trocar.Applied medical's instructions for use states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.This report represents the initial and final report.
Event or Problem Description
Procedure performed: unknown.Event description: the clear portion of the inside of the trocar fell apart inside of the patient¿s peritoneum during the procedure.All parts were retrieved from the patient.A new trocar was taken apart and the retrieved pieces were compared to the clear portion inside the new trocar and were found to be complete.It is unknown what procedure was being performed.It is unknown what instruments were in use at the time of the incident.No patient injury occurred and the event device is available for return.Patient status: no patient injury occurred as a result of the event.

• Brand Name: C0Q19, KII 8X100 Z-THR OPT SYS 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8038454
• Report Number: 2027111-2018-00411
• Device Sequence Number: 13863835
• Product Code: GCJ
• UDI-Device Identifier: 00607915115920
• UDI-Public: (01)00607915115920(17)210131(30)01(10)1316423
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2018

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: 01/31/2021
• Device Model Number: C0Q19
• Device Catalogue Number: 101063001
• Device Lot Number: 1316423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1