MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB33, 11X100 KII SH BLD ZTHR 6/BX; GCJ

Model Number	CTB33
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2016
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.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
Procedure performed - unknown - "rubber/plastic came off while the trocar was in the patient".Additional information received via email from (b)(6) at 8:56 am on july 6, 2016: i've had the following answers from the scrub nurse that was present: 'it was the rubber, 11mm port.The inner fell into the patient and yes it was retrieved.'.
Additional Manufacturer Narrative
Investigation summary: two units were returned for evaluation; the event unit and a representative unit from the same lot.Upon inspection of the event unit, engineering removed the seal and noted no damage to the duckbill.The duckbill was removed and the septum was found to be torn and missing a portion.The missing portion of the rubber was not returned.The representative unit met all current specifications and did not exhibit similar damage.All seals are thoroughly inspected and tested for leakage during the manufacturing process.The damage to the septum appears to have been caused by an instrument.There is always a potential to tear or dislodge the internal seal components with multiple passes of instruments, especially with sharp or angular devices.The instructions for use (ifu) warns that extra care should be used when inserting angular and asymmetrical instruments.All instruments should be centered axially when inserted through the seal to prevent tearing.Engineering is currently researching possible device enhancements intended to further minimize the potential for this type of incident to occur.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: CTB33, 11X100 KII SH BLD ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5784423
• Report Number: 2027111-2016-00510
• Device Sequence Number: 473266
• Product Code: GCJ
• UDI-Device Identifier: 00607915124250
• UDI-Public: (01)00607915124250(17)190303(30)01(10)1266227
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K072674
• 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): 06/16/2016

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: 03/03/2019
• Device Model Number: CTB33
• Device Catalogue Number: 101219501
• Device Lot Number: 1266227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2016
• Supplement Report FDA Received Date: 09/08/2016
• Patient Sequence Number: 1