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

Model Number	CTR33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event product is 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.There is no report of serious injury or death associated with this event.
Event or Problem Description
Ovary cystcy - "client set up this device to patient body.They use scope and see a small fragment of trocar in patient body.The fragment was moved from patient body.Patient status : "fine".
Additional Manufacturer Narrative
Investigation summary: the event product was returned for evaluation along with a green fragment.Engineering was able to confirm the customer's experience of the fragmented cannula tip.The wall thickness was tested and the cannula met all specifications.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.Although the exact 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.

• Brand Name: CTR33, 11X100 KII OPT ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6090187
• Report Number: 2027111-2016-00771
• Device Sequence Number: 16353981
• Product Code: GCJ
• UDI-Device Identifier: 00607915124236
• UDI-Public: (01)00607915124236(17)190330(30)01(10)1268245
• 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): 01/26/2017

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: 03/30/2019
• Device Model Number: CTR33
• Device Catalogue Number: 101219801
• Device Lot Number: 1268245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2016
• Supplement Report FDA Received Date: 01/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1