MAUDE Adverse Event Report: APPLIED MEDICAL CTB73, 12X100 KII SH BLD ZTHR 6/BX; GCJ

Model Number	CTB73
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2016
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 follow up 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
Procedure performed unknown - "the upper part of the device (white) got disassembled from its support without any possibility to set it back in plac.Loss of pneumoperitoneum.Trocar unusable." patient status - unknown.
Additional Manufacturer Narrative
The event product was not returned to applied medical for evaluation.This is consistent with the initial intake of the complaint which detailed that the product would not be returned.In the absence of the subject device, it is difficult to determine the root cause of the event.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.Although the root cause could not be determined, applied medical has opened a corrective and preventative action (capa) to further elevate and track this investigation and implement appropriate corrective actions to mitigate this type of event.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Event or Problem Description
Additional information received via email from team member on april 26, 2016: the entire seal housing detached.No pictures are available of the event device.

• Brand Name: CTB73, 12X100 KII SH BLD ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5596363
• Report Number: 2027111-2016-00326
• Device Sequence Number: 13652192
• Product Code: GCJ
• UDI-Device Identifier: 00607915123727
• UDI-Public: (01)00607915123727(17)180811(30)01(10)1252379
• 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): 12/12/2016

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: 08/11/2018
• Device Model Number: CTB73
• Device Catalogue Number: 101219601
• Device Lot Number: 1252379
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2016
• Supplement Report FDA Received Date: 12/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1