MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0415, 5X100MM SS REUSABLE CANNULA; GCJ

Model Number	C0415
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.According to telephone information, the sleeve of the trocar is very sharp.This damaged the insulation of other instruments.Additional information received by phone from sales representative on 25may2018: there are photos available, which will be sent soon.This and 4 additional event units are being returned.No patient injury or illness occur associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the event unit noted multiple scratches and a dent at the cannula tip.Testing was performed on the event unit.However, the complainant's experience could not be confirmed or replicated.Based on the condition of the returned unit, it is likely that the damage to the insulation of other instruments was caused by the dent in the cannula tip, which was a result of the way in which the unit was handled by the customer.The instructions for use (ifu) states, "prior to use, inspect the distal tip of the cannula for any dents or tip damage that may have occurred during handling and cleaning.Dents, nicks, or cracks in the distal tip of the cannula may prevent proper shield deployment, increase the potential for cannula fracture, and may render the cannula incompatible with certain instruments.Cannula with damaged tips should not be used." 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: C0415, 5X100MM SS REUSABLE CANNULA
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7783393
• Report Number: 2027111-2018-00265
• Device Sequence Number: 1229110
• Product Code: GCJ
• UDI-Device Identifier: 00607915114367
• UDI-Public: (01)00607915114367(11)130422(30)01(10)1195247
• Combination Product (Y/N): N
• PMA/510(K) Number: K932995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

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: Other
• Device Model Number: C0415
• Device Catalogue Number: 100332501
• Device Lot Number: 1195247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1