MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF73, 12X100 KII FIOS ZTHR 6/BX; GCJ

Model Number CTF73

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

The event device was returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure performed: total laparoscopic hysterectomy + bilateral salpingoophorectomy.Event description: during this procedure the surgeon used the ctf73 in question as the camera port and both the consultant and registrar commented that there was noticeable drag force on the scope inside the port.A 2nd 12 mm port was used as a lateral working port and when the camera was moved to this port to get a comparison of the drag force, the scope moved easily through it.It is worth noting that the 2nd 12 mm port was actually at ctb73 and the surgeon opted to take the sleeve from the ctb73 and re-use the fios obturator from the ctf73, so she could have non-bladed insertion for both ports (this case was part of a trocar evaluation and we didn't have enough stock on hand to use 2 ctf73s).I made sure to keep track of which 12 mm z thread sleeve belonged to which obturator so i am confident that the sleeve that is being returned is the ctf73 sleeve, not the ctb73 sleeve.After the procedure, i put gloves on and compared the feel of the drag force for the two sleeves using the scope and noticed a considerable difference between the two, with the ctf73 sleeve having much more drag on the scope.I could not see any damage to the sleeve, although its double duckbill looked a little more dry/less lubricated than the ctb73 sleeve seal.The main impact on the procedure was that the increased drag made it more difficult to fully advance the scope when the surgeon was working low down in the patient's pelvis so the she was not able to view the working area as closely as she needed to.Only the scope was used down the port in question, but other items used through the other ports included johan graspers, sutures, needle holders, [and energy devices].Patient status: no patient injury or illness occurred associated with the complaint event.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection noted that the shield, a clear plastic internal component of the seal, was slightly dislodged.Testing was performed on the event unit, which confirmed the reported event.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by the dislodged shield, which was likely not fully secured during manufacturing.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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: CTF73, 12X100 KII FIOS ZTHR 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7245071
• MDR Text Key: 99325724
• Report Number: 2027111-2018-00033
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703(17)200910(30)01(10)1304090
• Combination Product (y/n): N
• PMA/PMN Number: K041795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/10/2020
• Device Model Number: CTF73
• Device Catalogue Number: 101219101
• Device Lot Number: 1304090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Date Manufacturer Received: 01/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JOHAN GRASPERS, SUTURES, NEEDLEHOLDERS; LIGASURE AND SONICISION, CTB73 SLEEVE