MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR71, KII 12X150 Z-THR OPT SEP SYS 6/BX; GCJ

Model Number	4
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2017
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: turp with da vinci robotic surgery.Event description: "in surgery, this device was used with endoscope but it was broken in patient body suddenly." photograph provided.Type of intervention: no patient injury or illness occurred associated with the event patient status: "fine".
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Upon inspection, engineering was able to confirm the complainant's experience of a fractured cannula.The wall thickness of the cannula was measured and was found to be uneven.The likely root cause of the fracture is the uneven cannula wall thickness, which occurred during the injection molding process of the cannula.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible process enhancements intended to further minimize the potential for this type of incident to occur.

• Brand Name: CTR71, KII 12X150 Z-THR OPT SEP SYS 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6644186
• Report Number: 2027111-2017-01858
• Device Sequence Number: 13656948
• Product Code: GCJ
• UDI-Device Identifier: 00607915125042
• UDI-Public: (01)00607915125042(17)190815(30)01(10)1276446
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: 4
• 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): 07/13/2017

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: 08/15/2019
• Device Model Number: 4
• Device Catalogue Number: 4
• Device Lot Number: 1276446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DAVINCI ROBOT; ENDOSCOPE