MAUDE Adverse Event Report: APPLIED MEDICAL CTR33, 11X100 KII OPT ZTHR 6/BX; GCJ

Model Number	CTR33
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent 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
Laparoscopic gynecological surgery - "air leak".Patient status - "fine".
Additional Manufacturer Narrative
Additional information received.Investigation summary: the event unit was returned for evaluation.Engineering performed seal leak testing and verified that the seal function as intended.The distance between the latch tabs, which attach the seal to the cannula, was measured and was found to be out of specification.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.The root cause of the air leakage is possibly due to the seal dislodging from the cannula.Although the root cause could not be confirmed, 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 distributor on april 25, 2016: the air leak was "rapid" and there was no loss of visualization.

• Brand Name: CTR33, 11X100 KII OPT ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5651757
• Report Number: 2027111-2016-00368
• Device Sequence Number: 181556
• Product Code: GCJ
• UDI-Device Identifier: 00607915124236
• UDI-Public: (01)00607915124236(17)181220(30)01(10)1261426
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K060096
• 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): 12/07/2016

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: 12/20/2018
• Device Model Number: CTR33
• Device Catalogue Number: 101219801
• Device Lot Number: 1261426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2016
• Supplement Report FDA Received Date: 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1