MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF33, 11X100 KII FIOS ADVFIX 6/BX; GCJ

Model Number	CFF33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Event description: the internal valve of the trocar was torn off without having forced + a piece of valve was found inside the patient during the procedure original: la valve interne du trocart s'est arrachée sans avoir forcé + un morceau de valve a été retrouvé à l'intérieur du patient pendant l'intervention.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.Based on the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instruments through the trocar.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.
Event or Problem Description
Patient status is fine.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a rubber fragment.Visual inspection confirmed the complainant's experience of seal component separation.The rubber fragment completed the missing portion on the septum, a rubber component of the seal.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instruments through the trocar.Applied medical's instructions for use (ifu) 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.

• Brand Name: CFF33, 11X100 KII FIOS ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7118775
• Report Number: 2027111-2017-02142
• Device Sequence Number: 1450290
• Product Code: GCJ
• UDI-Device Identifier: 00607915119942
• UDI-Public: (01)00607915119942(17)180716(30)01(10)1250454
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083638
• 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,Followup
• Report Date (Section B): 03/27/2018

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: 07/16/2018
• Device Model Number: CFF33
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 11/16/2017; 11/16/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/16/2018; 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1