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	06/16/2017
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 investigati.
Event or Problem Description
Procedure performed - "ladg"."this is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation." "report from the sales rep: during a procedure, the customer noted a rubber fragment inside abdominal cavity.The fragment was removed from the patient using a grasper, and the procedure was successfully completed.No patient injury and bleeding.The ddb was cut for the inspection of the customer.Please see the cer check list for inserted instruments into the trocar."initial investigation report: the event unit was returned to us and visually inspected.The septum was fragmented.The returned rubber material(the size: approx.3.5mm x 2.0mm) matched the missing location on the septum.The unit will be returned to (b)(4) for further evaluation.Admin#(b)(4)." patient status - no patient injury.
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation with a rubber fragment.Upon visual inspection, engineering observed that the internal rubber components of the seal, the septum and duckbill, were fragmented.The rubber fragment returned completed the septum when reassembled.Based on the description of the event, the damage observed on the duckbill was caused by the complainant, who intentionally cut the duckbill for inspection.The likely root cause of the damage to the septum is 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: 6712289
• Report Number: 2027111-2017-01912
• Device Sequence Number: 2013724
• Product Code: GCJ
• UDI-Device Identifier: 00607915119898
• UDI-Public: (01)00607915119898(17)190819(30)01(10)1276900
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2017

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: 08/19/2019
• Device Model Number: CFR73
• Device Catalogue Number: 101256001
• Device Lot Number: 1276900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1