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	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Event or Problem Description
Robotic assisted prostatectomy - "during the procedure the cannula is broken.There was no unusual instrument changing." additional information received by email from an applied medical representative on november 16, 2016: i talked with the operating room team.The sleeve is broken during the surgery (davinci prostatectomie) - the ctb71 was the optictrocar.There was no manipulation - only a low pressure and the sleeves were broken.At the picture you can see the flaw.No plastic fragments were left in the cavity.Due to quality reasons customer does not want to use the remaining products from the same lot.Type of intervention - "n/a".Patient status - "ok".
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.Applied medical continuously seeks to improve the form, function and ease of use of its products and will continue to monitor its vigilance system for trends and take appropriate actions as necessary.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: 6172527
• Report Number: 2027111-2016-00880
• Device Sequence Number: 18976531
• Product Code: GCJ
• UDI-Device Identifier: 00607915125066
• UDI-Public: (01)00607915125066(17)190414(30)01(10)1268783
• Combination Product (Y/N): N
• 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): 02/06/2017

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: 04/14/2019
• Device Model Number: CTB71
• Device Catalogue Number: 101415501
• Device Lot Number: 1268783
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 02/06/2017
• Patient Sequence Number: 1