MAUDE Adverse Event Report: APPLIED MEDICAL CTF35, 11X100 KII FIOS Z-THREAD DP 10/BX; GCJ

Model Number	CTF35
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Lap.Tapp (hernia repair) - "a piece of the seal fell into the situs after atraumatic insertion of the divices.The piece of the seal, could be retrieved." patient status - "ok".
Additional Manufacturer Narrative
Additional information was requested from the customer and provided.Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering removed the seal and noted no damage to the duckbill, however, when the duckbill was removed the septum was found to be torn and missing a portion.The missing portion of the rubber was returned and matches where the hole in the septum is located.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections.All seals are thoroughly inspected and tested 100% 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 the initial report was submitted, then the supplemental report will be submitted to the fda.

• Brand Name: CTF35, 11X100 KII FIOS Z-THREAD DP 10/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5665566
• Report Number: 2027111-2016-00392
• Device Sequence Number: 13497714
• Product Code: GCJ
• UDI-Device Identifier: 00607915129880
• UDI-Public: (01)00607915129880(17)190131(30)01(10)1264292
• Combination Product (Y/N): N
• PMA/510(K) Number: K041795
• 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): 04/19/2016

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: 01/31/2019
• Device Model Number: CTF35
• Device Catalogue Number: 101299701
• Device Lot Number: 1264292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1