MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R83, 12X60 KII OPT ZTHR 6/BX; GCJ

Model Number	C0R83
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: "gastrectomy".Event description: "the tip of the trocar cannula was broken when they pulled back the retrieval bag during surgery".Additional information received via email from (b)(6) sales manager on august 10, 2017 - the cannula tip simply particulated.One piece was chipped off.It was a notable size piece fallen into the patient body.It was retrieved with no special injury.Type of intervention: na.Patient status: "no special injury".
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a fractured cannula tip.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by material degradation during the injection molding process, which could cause the part to be more prone to fractures.The removal of the instrument from the cannula likely caused the cannula tip to fracture.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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: C0R83, 12X60 KII OPT ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6836262
• Report Number: 2027111-2017-01958
• Device Sequence Number: 65031
• Product Code: GCJ
• UDI-Device Identifier: 00607915116668
• UDI-Public: (01)00607915116668(17)190323(30)01(10)1267822
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K060096
• 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): 09/28/2017

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: 03/23/2019
• Device Model Number: C0R83
• Device Catalogue Number: 101218501
• Device Lot Number: 1267822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1