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 Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device 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
Lap scope diagnosis - "trocar leaked air when they put it in." patient status - n/a.
Additional Manufacturer Narrative
Investigation summary: the event product was returned for evaluation.Engineering performed visual inspection and found no signs of damage.A leak test was performed on the returned unit and the unit performed as intended and met all current specifications.The customer's experience could not be replicated by engineering.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.Although the root cause of the experience could not be determined, 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 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 13, 2016: the air leak was "a rapid leakage." after the air leak, "visualization wasn't lost completely but the abdomen wasn't properly insufflated (when obturator was taken out -air was just rapidly lost through trocar-leakage stopped when lense was put in)".Additional information received via email from distributor on april 20, 2016: the leaking was noticed "after trocar was inserted in the patient-the co2 was connected to the stop cock and when the stop cock was opened to let co2 in- the leakage occured immediately." a "30° lense" was used in conjunction with the trocar.When the leaking occured, "no instrument was used with the trocar".

• 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: 5651819
• Report Number: 2027111-2016-00365
• Device Sequence Number: 293179
• Product Code: GCJ
• UDI-Device Identifier: 00607915124236
• UDI-Public: (01)00607915124236(17)180629(30)01(10)1248175
• 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,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: 06/29/2018
• Device Model Number: CTR33
• Device Catalogue Number: 121219801
• Device Lot Number: 1248175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2016
• 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