MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF75, 12X100 KII FIOS Z-THREAD DP 10/BX; GCJ

Model Number	CTF75
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation with a rubber fragment.Upon inspection, engineering noted fragmentation of an internal rubber component of the seal.The rubber fragment returned matched the missing portion on the seal.The likely root cause of the damage to the seal is an instrument.Applied medical's instructions for use states 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 will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.This report represents the combined initial and final.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: equipment used - [competitor] clip applier, reusable graspers, disposable scissors.As mr [name] completed his laparoscopic procedure he noticed a piece of black material inside the patient.He subsequently removed this item and noticed this was a piece of black rubber.He therefore inspected the ports and discovered that one of the ctf75 ports showed a corresponding piece missing from the inner double duck bill seal.This was reported to myself and the patient.The procedure was completed and the patient recovered as expected.Patient status: did a patient injury or illness occur associated with the complaint event? no.

• Brand Name: CTF75, 12X100 KII FIOS Z-THREAD DP 10/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6854090
• Report Number: 2027111-2017-02008
• Device Sequence Number: 518171
• Product Code: GCJ
• UDI-Device Identifier: 00607915129903
• UDI-Public: (01)00607915129903(17)200315(30)01(10)1292355
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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
• Report Date (Section B): 09/08/2017

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: Health Professional
• Device Expiration Date: 03/15/2020
• Device Model Number: CTF75
• Device Catalogue Number: 101299901
• Device Lot Number: 1292355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1