MAUDE Adverse Event Report: UNISENSOR AG UNITIP CATHETER FOR HR GI; HRUNITIP HIGH RESOLUTION CATHETER

Model Number K12959-L5-1038-D

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, unisensor (b)(4) received an initial incident report from an end-user in (b)(6)(bfarm case number: (b)(6)).The description of the incident offered by the end-user was that unisensor's cleaning instruction for probe k12959-l5-1038-d recommended a mechanical cleaning procedure with the wassenburg wd440 reprocessing machine for flexible endoscopes.However, the mfr of the wassenburg wd440 informed the end-user that they did not release their equipment for an effective cleaning of such small lumen.The end-user believes that if one would complete a cleaning procedure with a wassenburg wd440 machine there would be a theoretical risk of infection to the pt.Note: no pt has involved in the event.Unisensor (b)(4) is registered with the (b)(4) as specification developer of this device and this event was initially reported in (b)(6) which affects directly unisensor ag.Nevertheless, unisensor usa inc.Which is also registered with the (b)(4) is the mfr of the devices marketed in the usa and thus the corrective action will be handled by unisensor usa inc.Due to the above mention arguments, unisensor (b)(4) believes that it has in place enough mitigation actions that prevent the risk of infection due to incorrect reprocessing of a lumened catheter and it has done all it can to provide the end-user of adequate instructions to complete this procedure in a safe manner for pts.Thus, unisensor upholds the view that if one reads all available instructions included in the product's ifu and additional info leaflet, there is only one unambiguous way to reprocess the lumen safely, which has been validated and is described in detail in the ifu.The safest reprocessing procedure for lumened catheters is the manual procedure described in the ifu and if the end-user wishes to use a mechanical method then as its stated in the info leaflet it should "take care that only proven procedures and solutions are used for cleaning/ disinfection / sterilization".In the view of unisensor the end-user in this case proceeded correctly when inquiring with the equipments mfr (wassenburg medical b.V.) if it could reprocess the unitip catheter.The feedback from the mfr of the reprocessing equipment was clear and it should have been followed by the end-user.Nothing specified in the existing ifu contradicted the feedback given by the wassenburg medical b.V.And both ifu and mfr's feedback are in harmony and thus the hypothetical risk claimed by the end-user is not existent.Nevertheless, in an effort for constant improvement, unisensor (b)(4) will take further action in an attentive to mitigate a risk that has already been reduced "as-far-as-possible".

Manufacturer Narrative

Unisensor (b)(4) proceeded to necessary investigations to establish the root cause of the issue and these are the findings which constitute the mfr's response comments: catheter was sold to our distributor in (b)(4) on the (b)(4) 2013.Unisensor (b)(4) mfr is not informed to where the products are resold and rely on the distributors network to provide the correct info.In this instance, included within the medical device packaging was the instructions for use manual ref.(b)(4).In the view of unisensor (b)(4) the ifu version eco13-1801 contains a very accurate description of how to reprocess the lumen in points 4.3- cleaning (manual procedure), 4.4 disinfection (manual procedure) and 5.3.3 application for lumen.Nowhere in the ifu can one read that unisensor's lumens can be reprocessed through the mechanical procedure.If one reads point 4.5 cleaning/disinfection (mechanical procedure) it makes absolutely no reference that it applies to lumened catheters.In the ifu reprocessing of the lumen is always consistently described as a manual process.Unisensor also makes available a leaflet which contains all authorized reprocessing solutions and equipment.This document only states that the listed products do not damage the catheters.Corrective and preventive actions: unisensor's instructions for use and info leaflet will be changed to include an advisory text regarding the reprocessing of lumened catheters.Distributors will be notified of actions through a notification message which will be spread via email and posted on unisensor's website.Distributors need to ensure that end-user receives adequate training to include also how to correctly reprocess lumened catheters and will be requested to pass on the notification to all end-users that hold devices with the reference k12959-l5-1038-d.

• Brand Name: UNITIP CATHETER FOR HR GI
• Type of Device: HRUNITIP HIGH RESOLUTION CATHETER
• Manufacturer (Section D): UNISENSOR AG
• Manufacturer Contact: susana mogensen ; bahnstrasse 12a; attikon CH-85-44 ; SZ CH-8544
• MDR Report Key: 4066324
• MDR Text Key: 4811665
• Report Number: 9710639-2014-00002
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K12959-L5-1038-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other