MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS22, 12X100 KII SLEEVE ADVFIX 12/BX; GCJ

Model Number	CFS22
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation with a rubber fragment.Upon inspection, engineering noted fragmentation of an internal rubber component of the seal.The rubber fragment returned did not complete the seal when reassembled.The likely root cause of the damage to the seal 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.This report represents the initial and final report.
Event or Problem Description
Procedure performed: "laparoscopic prostatectomy" event description: " this is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation." "septum damaged" "report from the sales rep the doctor noted a black fragment inside abdominal cavity in the field of view of a scope camera.As the result of inspecting the devices potentially caused the incident, he/she confirmed that a portion of the septum was fragmented.It was assumed that the incident caused during manipulating a forceps.Laparoscopic prostatectomy procedure was performed.The fragment was removed, the trocar was replaced with new one and the procedure was completed.No patient injury and less bleeding.It was reported that the doctor had a sign of roughly handling some devices inside the trocar.The number of inserted devices into the trocar was large.The cer check list is unavailable.Initial investigation report the event unit was returned to us and visually inspected.The septum was fragmented(fig.1).The returned fragment size was approx.8.0mm x 5.5mm.The fragment matched the missing portion on the septum in shape(fig.2).However, we noted a missing portion on the septum(fig.3).No damage was observed on the ddb and the shield.The unit will be returned to amr for further evaluation.Admin# (b)(4)." type of intervention: "the trocar was replaced with new one" patient status: "no patient injury".

• Brand Name: CFS22, 12X100 KII SLEEVE ADVFIX 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6813840
• Report Number: 2027111-2017-01929
• Device Sequence Number: 1077942
• Product Code: GCJ
• UDI-Device Identifier: 00607915117740
• UDI-Public: (01)00607915117740(17)191109(30)01(10)1282867
• 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
• Report Date (Section B): 08/23/2017

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: Health Professional
• Device Expiration Date: 11/09/2019
• Device Model Number: CFS22
• Device Catalogue Number: 101245301
• Device Lot Number: 1282867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1