MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB71, KII 12X150MM SHLD BLD Z-THR, 6/BX; GCJ

Model Number	CTB71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.There is no report of serious injury or death associated with this event.
Event or Problem Description
By-pass + cholecystectomy - "nature of incident: the tip of the trocar broke during the intervention in the patient's abdomen." additional information from sales rep sent august 17, 2016: there is no information on how the fracture occurred.The surgeon noticed the fracture at the end of the procedure when he wanted to remove the trocar.The fracture was a clean break and the port was used as an ancillary port.It was a standard method of insertion knowing that this is a bladed trocar.Patient status - "patient is ok".Type of intervention - "consequences: the surgeon immediately removed the trocar and managed to recover the broken tip.".
Additional Manufacturer Narrative
Additional information was requested from the customer and provided.Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed the cannula was fractured.The root cause of this incident is likely due to manufacturing.Engineering took dimensional measurements of the wall thickness of the cannula and found that the wall thickness did not meet specifications.Engineering believes the fracture observed could have been a result of this uneven wall thickness.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this continuous process, applied medical is currently researching possible process enhancements intended to further minimize the potential for this type of event to occur.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: CTB71, KII 12X150MM SHLD BLD Z-THR, 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5948359
• Report Number: 2027111-2016-00629
• Device Sequence Number: 473152
• Product Code: GCJ
• UDI-Device Identifier: 00607915125066
• UDI-Public: (01)00607915125066(17)190203(30)01(10)1264757
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072674
• 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): 08/16/2016

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: 02/03/2019
• Device Model Number: CTB71
• Device Catalogue Number: 101066301
• Device Lot Number: 1264757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 11/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1