MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR73, 12X100 KII OPT ADVFIX 6/BX; GCJ

Model Number	CFR73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2017
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 the investigation.
Event or Problem Description
Procedure performed: "laparoscopic nephrectomy"."this is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation.Septum fragmentation.Report from the sales rep: a foreign material fell off inside abdominal cavity.It was removed from patient and the surgery was successfully completed.During inspection on the trocar post-treatment, the customer noted the trocar valve was fragmented and the foreign material comes from the trocar valve.Intraperitoneal irrigation was performed during the case.No patient injury.Initial investigation report: the event unit was returned to us and visually inspected.The ddb was removed by the customer for inspection.The septum was fragmented.The returned fragment (size: 1.5mm x 2.5mm) matched the missing location on the septum.The unit will be returned to amr for further evaluation.Admin# (b)(4).Type of intervention: "it was removed from patient and the surgery was successfully completed".Patient status: "no patient injury".
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 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.

• Brand Name: CFR73, 12X100 KII OPT ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7121353
• Report Number: 2027111-2017-02147
• Device Sequence Number: 1411368
• Product Code: GCJ
• UDI-Device Identifier: 00607915119898
• UDI-Public: (01)00607915119898(17)190201(30)01(10)1264230
• Combination Product (Y/N): N
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/01/2019
• Device Model Number: CFR73
• Device Catalogue Number: 101256001
• Device Lot Number: 1264230
• 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: 11/21/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1