MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR73, 12X100 KII OPT ADVFIX 6/BX; GCJ

Model Number	3
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic nephrectomy, event description: "this is a complaint from the market.(b)(4).Please refer to the complaint sheet for investigation." report from the sales rep: the surgeon noted that when inserting the second trocar(model name:unknown) as working port, the distal end of the cannula of the first trocar as camera port contacted the non-sharp tip of the obturator of the second trocar, causing the distal end of the first trocar to be fragmented inside abdominal cavity.On confirming the fragment, it was removed from patient.He/she determined that the fragment matched a missing portion on the cannula.The event trocar was replaced with new one, and the procedure was successfully completed.The second trocar without any fragments was disposed of.He/she cannot admit the obturator second trocar with a round-shaped and non-sharp tip contact with cannula of the first trocar without any angular points causes the incident because they don't get stuck in each other.Initial investigation report by aomori olympus: the event unit and one(1) fragment were returned to olympus and visually inspected.The distal end of the cannula was missing a portion.The returned fragment size was approx.4.5 mm x 7.0 mm.The fragment matched a missing portion on the cannula.The unit will be returned to amr for further evaluation.(b)(4).Type of intervention: na patient status: "no patient injury".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon inspection, engineering was able to confirm the complainant's experience of a fractured cannula tip.The root cause of the cannula tip fracture is likely external force applied on the tip in combination with lipid exposure.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.

• Brand Name: CFR73, 12X100 KII OPT ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6641562
• Report Number: 2027111-2017-01829
• Device Sequence Number: 613470
• Product Code: GCJ
• UDI-Device Identifier: 00607915119898
• UDI-Public: (01)00607915119898(17)190819(30)01(10)1276900
• Combination Product (Y/N): N
• PMA/510(K) Number: 3
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2017

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: Other
• Device Expiration Date: 08/19/2019
• Device Model Number: 3
• Device Catalogue Number: 3
• Device Lot Number: 1276900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1