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	09/11/2017
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" event description: "this is a complaint from the market.(b)(4).Please refer to the complaint sheet for investigation.Septum fragmentation: report from the sales rep: the customer noted that a fragment of the trocar septum fell off inside abdominal cavity.He/she remove the fragment from abdominal cavity, and confirmed it matched the missing section on the septum in shape.The procedure(laparoscopic nephrectomy) was successfully completed with the event unit.The patient status is ok.The cer check list is unavailable.Initial investigation report: the event unit was returned to us and visually inspected.The double duck bill was removed from the seal by the facility for inspection.The septum was fragmented.The returned fragment(size: 7.0 mm x 6.5 mm) matched the missing section on the septum in shape.The unit will be returned to amr for further evaluation.(b)(4)." type of intervention: "he/she remove the fragment from abdominal cavity, and confirmed it matched the missing section on the septum in shape.The procedure(laparoscopic nephrectomy) was successfully completed with the event unit." 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 fragmentation of an internal rubber component of the seal, the septum.The rubber fragment returned matched the missing portion on the septum when reassembled.The duckbill, another rubber component of the seal, was observed to be detached from the seal.Based on the description of the event, the duckbill was intentionally removed by the complainant for inspection.Based on the condition of the returned unit, it is likely that the reported event was caused by an instrument.The instructions for use (ifu) states, "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: 6980379
• Report Number: 2027111-2017-02079
• Device Sequence Number: 13564104
• Product Code: GCJ
• UDI-Device Identifier: 00607915119898
• UDI-Public: (01)00607915119898(17)200405(30)01(10)1293727
• 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): 11/10/2017

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: 04/05/2020
• Device Model Number: CFR73
• Device Catalogue Number: 101245601
• Device Lot Number: 1293727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1