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

Model Number	CTR33
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/14/2016
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
Lap diagnostic - "when o2 is connected to stopcock and stopcock open to let o2 in - then the o2 leaks rapidly out of the trocar.".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.The trocar was returned with the obturator inside the cannula and seal, causing the stretching and incomplete closure of the internal rubber components of the seal.Engineering functionally tested the unit, and it did not meet acceptance criteria due to the stretched and incomplete closure of the internal rubber components of the seal.The complainant's experience could not be replicated.The root cause of the loss of co2 could not be determined.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of its products.

• 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: 5654915
• Report Number: 2027111-2016-00375
• Device Sequence Number: 13529718
• Product Code: GCJ
• UDI-Device Identifier: 00607915124236
• UDI-Public: (01)00607915124236(17)180824(30)01(10)1253002
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K060096
• 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): 03/14/2017

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: 08/24/2018
• Device Model Number: CTR33
• Device Catalogue Number: 101219801
• Device Lot Number: 1253002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2016
• Supplement Report FDA Received Date: 03/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1