MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF74, KII 12X100 FIOS Z-THR HN 6/BX; GCJ

Model Number	CTF74
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2016
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.There is no report of serious injury or death associated with this event.
Event or Problem Description
"doctor (b)(6) was doing a lap tubal and part of the rubber air seal broke off.She noticed it immediately and was able to easily remove it from the patient." "no harm was done to the patient.".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon visual inspection, the fragmented septum was confirmed.During the manufacturing process, all trocars are thoroughly inspected and tested for functionality and performance prior to packaging.The septum was likely damaged by an instrument.There is always a potential to tear or dislodge the internal seal components with sharp or angular instruments.The instructions for use (ifu) warns that "extra care should be used when inserting angular and asymmetrical instruments, such as "j" hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." applied medical has opened a corrective and preventative action report to further elevate and track this investigation and implement appropriate corrective actions to mitigate this type of event.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: CTF74, KII 12X100 FIOS Z-THR HN 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6042577
• Report Number: 2027111-2016-00704
• Device Sequence Number: 19292311
• Product Code: GCJ
• UDI-Device Identifier: 00607915123710
• UDI-Public: (01)00607915123710(17)190510(30)01(10)1270422
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• 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): 12/13/2016

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: 05/10/2019
• Device Model Number: CTF74
• Device Catalogue Number: 101470925
• Device Lot Number: 1270422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2016
• Supplement Report FDA Received Date: 12/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FILSHIE CLIP APPLIER