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U.S. Department of Health and Human Services

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

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APPLIED MEDICAL RESOURCES CTF73, 12X100 KII FIOS ZTHR 6/BX GCJ Back to Search Results
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.

 
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Brand NameCTF73, 12X100 KII FIOS ZTHR 6/BX
Type of DeviceGCJ
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
wendy kobayashi
22872 avenida empresa
rancho santa margarita, CA 92688
9497138059
MDR Report Key7245071
MDR Text Key99325724
Report Number2027111-2018-00033
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeGB
PMA/PMN NumberK041795
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device EXPIRATION Date09/10/2020
Device MODEL NumberCTF73
Device Catalogue Number101219101
Device LOT Number1304090
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/29/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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