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
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.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 via email on november 16, 2016 from an applied medical representative: "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.In the picture the flaw can be seen.No plastic fragments were left in the cavity." a second cer will follow for another lot with same batch, second cer is (b)(4).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
Investigation summary: the event product was returned to applied medical for evaluation, along with five sterile units from the same lot.The five sterile units were inspected and no visible damage to the devices were observed.Upon inspection of the event unit, engineering noted the cannula was broken in half.The probability and criticality of harm resulting from this failure mode has been evaluated and found to be at an acceptable level.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: 6172528
• Report Number: 2027111-2016-00877
• Device Sequence Number: 928798
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• 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
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1