MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF03, 5X100 KII FIOS ADVFIX 6/BX; GCJ

Model Number	2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2017
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
Procedure performed: laparoscopy.Event description: "[name] from (b)(6), reported to our sales specialist that upon opening of the trocar and sleeve, the end of the sleeve was broken and flattened." patient status: n/a.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon inspection, engineering was able to confirm the complainant's experience; fractures were observed at the cannula tip.Upon further inspection, scratches were observed on the cannula and the syringe showed signs of damage.Based on the condition of the returned unit and the description of the event, it is possible that the unit was damaged during shipping and distribution or from mishandling after leaving applied medical facilities.However, the root cause could not be confirmed.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: CFF03, 5X100 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: 6725403
• Report Number: 2027111-2017-01896
• Device Sequence Number: 13646117
• Product Code: GCJ
• UDI-Device Identifier: 00607915117641
• UDI-Public: (01)00607915117641(17)200208(30)01(10)1289128
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: 2
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2017

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: Other
• Device Expiration Date: 02/08/2020
• Device Model Number: 2
• Device Catalogue Number: 2
• Device Lot Number: 1289128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1