MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF71, 12X150 KII FIOS ADVFIX 6/BX; GCJ

Model Number	CFF71
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: magenbypass / gastric bypass.Original: op pfleger berichtet, dass die trokarhülse an der unteren öffnung komplett zersplittert sein.Er selbst war bei dem eingriff nicht dabei und der anwender konnte bisher nicht befragt werden.Weitere details folgen.Translation ame: operating room nurse said, that the cannulas are completely splintered at the lower opening.He himself was not present during the surgery and the user could not be asked yet.More information will follow.Additional information received from sales representative by email on (b)(6) 2018: only 1 trocar was splintered.I just talked to professor (b)(6), he was the user who complained about the trocar.At the end of the surgery, he wanted to change the camera and noticed that the bottom of the sleeve was "crumbled".He has operated as usual and has not noticed any impact of the instruments against the sleeve.Professor (b)(6) was unable to detect any broken plastic parts in the patients abdomen, but asks for information if we find that parts of the sleeve are missing.Type of intervention: none.Patient status: na.
Event or Problem Description
Procedure performed: magenbypass / gastric bypass.Original: op pfleger berichtet, dass die trokarhülse an der unteren öffnung komplett zersplittert sein.Er selbst war bei dem eingriff nicht dabei und der anwender konnte bisher nicht befragt werden.Weitere details folgen.Translation ame: or-nurse said, that the cannulas are completely splintered at the lower opening.He himself was not present during the surgery and the user could not be asked yet.More information will follow.Additional information received from sales representative by email on 22oct2018: only 1 trocar was splintered.I just talked to professor [name], he was the user who complained about the trocar.At the end of the surgery, he wanted to change the camera and noticed that the bottom of the sleeve was "crumbled".He has operated as usual and has not noticed any impact of the instruments against the sleeve.Professor [name] was unable to detect any broken plastic parts in the patients abdomen, but asks for information if we find that parts of the sleeve are missing.Additional information received from sales representative by email on 28nov2018: no unusual force was applied when inserting the trocar.Type of intervention: none.Patient status: na.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a cannula tip fracture.Cracks and breaks were observed along the cannula shaft.Based on the condition of the returned unit and the description of the event, it is likely that the cannula damage was caused by an instrument or object that came into contact with the cannula tip during the procedure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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: CFF71, 12X150 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: 8085194
• Report Number: 2027111-2018-00432
• Device Sequence Number: 13515875
• Product Code: GCJ
• UDI-Device Identifier: 00607915123048
• UDI-Public: (01)00607915123048(17)210424(30)01(10)1322729
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2019

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: 04/24/2021
• Device Model Number: CFF71
• Device Catalogue Number: 101255901
• Device Lot Number: 1322729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1