MAUDE Adverse Event Report: APPLIED MEDICAL CTR03, 5X100 KII OPT ZTHR 6/BX; GCJ

Model Number	CTR03
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2016
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 the investigation.
Event or Problem Description
Lap chole - "surgeon was performing procedure and noticed plastic coils that appeared to come from trocar." patient status - "discharged".
Additional Manufacturer Narrative
Investigation summary: the cannula from the trocar was returned for evaluation; the ca500 clip applier was not returned.In addition, a photograph was provided to show the plastic shavings surgeon noticed while performing procedure.Upon visual inspection of the returned, skived material was noted near the seal and at the bottom of the cannula.As the clip applier was not returned, it is difficult to determine the root cause of the incident.Although the exact root cause of the incident could not be confirmed, the engineering evaluation revealed that the likely root cause may be due to the distal end of the cover tube of the clip applier being flared out near the jaws causing interference when inserted into the trocar, thus resulting in the creation of the plastic shavings.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: CTR03, 5X100 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: 5581511
• Report Number: 2027111-2016-00295
• Device Sequence Number: 11010250
• Product Code: GCJ
• UDI-Device Identifier: 00607915123482
• UDI-Public: (01)00607915123482(17)181214(30)01(10)1260277
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2016

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: 12/14/2018
• Device Model Number: CTR03
• Device Catalogue Number: 101138201
• Device Lot Number: 1260277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2016
• Supplement Report FDA Received Date: 12/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1