MAUDE Adverse Event Report: COOK IRELAND LTD DISPOSABLE ENDOSCOPIC CLEANING BRUSH; MNL ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPES

Catalog Number DCB-SV-50

Device Problems Component Falling (1105); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Foreign body, removal of (2365)

Event Date 12/16/2013

Event Type  Injury  

Event Description

The duodenoscope was in the duodenum (4.2mm channel).A sphincterotome was passed down the channel and a plastic pancreatic stent (reported to be a zpsof-5-4) remaining in the endoscope from the previous patient fell out of the scope into this patient.The endoscope had been cleaned and disinfected prior to this occurrence in the usual manner using a dcb-sv-50 endoscopic cleaning brush.The pancreatic stent was retrieved using a stent retriever.Steps have been taken (bloods) to assess if the patient has any cross infection or contamination.In the previous procedure which resulted in the pancreatic stent remaining in the endoscope - a trainee doctor had failed to place the stent correctly and the stent was withdrawn with the endoscope.This report assesses the cleaning brush not adequately cleaning the endoscope which caused the pancreatic stent to remain in the endoscope and become a foreign body situation with the potential for cross contamination for this patient.An additional complaint has been opened in relation to the pancreatic stent (zpsof-5-4) and a separate report will be submitted in relation to this device.Plastic stent was retrieved with stent grabbers.Additional procedures due to this occurrence: bloods were taken to ascertain if any cross infection had occurred.Results of blood tests have not been received to date.

Manufacturer Narrative

This report assesses the cleaning brush not adequately cleaning the endoscope which caused the pancreatic stent to remain in the endoscope and become a foreign body situation with the potential for cross contamination for this patient.An additional complaint has been opened in relation to the pancreatic stent (zpsof-5-4) and a separate report will be submitted in relation to this device.The customer provided the following feedback: the duodenoscope was in the duodenum.A sphincterotome was passed down the channel and the plastic pancreatic stent from the previous patient fell out of the scope into this patient.The scope had been cleaned and disinfected in the usual way.The question was 'how could the brush pass the stent?' the actual lot number of the device involved in this complaint was not provided; therefore it was not possible to establish if there were any devices from the affected lot number in stock at the time of the complaint investigation.The device involved in the complaint was not returned for evaluation.With the information provided, a document based investigation was carried out.Dcb-sv-50 devices are single endoscopic cleaning brushes with a valve brush packaged in pre-printed packaging.Prior to distribution all dcb-sv-50 brushes are subjected to inspection to ensure device integrity.A review of the manufacturing records for the product involved in this complaint could not be performed as the lot number was not provided.The disposable endoscopic cleaning brush is intended for cleaning the accessory channels of endoscopes.The device is supplied non sterile and is intended for single use only.The dcb-sv-50 product consists of a 6.5 - 5.0 mm single cleaning brush of length 240cm and a 10.0 mm/ 6.0 - 4.5 mm valve brush.The minimum accessory channel required for use of these cleaning brushes is 2.0mm.It is standard that users are trained in the technique for cleaning/disinfecting scopes and recommended practice is to look for three successive clean passes through the scope with the brush before assuming the scope is clean.It was reported that the pancreatic stent that remained in the scope during the cleaning process was thought to be zpsof-5-4.This is a 5fr diameter stent, which would have an outer diameter of approximately 1.67mm.The endoscope accessory channel size was 4.2mm.Therefore it would be expected that there would not be a clean pass through the scope when using the 6.5 - 5.0 mm cleaning brush.A possible cause of this complaint could be the technique used for cleaning/disinfecting the scope.As actual use and cleaning conditions cannot be replicated in a laboratory setting, it is not possible to conclusively determine the cause of this complaint.It was not possible to conclusively determined a cause for this complaint.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: DISPOSABLE ENDOSCOPIC CLEANING BRUSH
• Type of Device: MNL ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPES
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan ; EI ; 61334440
• MDR Report Key: 3591373
• MDR Text Key: 4035497
• Report Number: 3001845648-2014-00004
• Device Sequence Number: 1
• Product Code: MNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: CLASS I N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DCB-SV-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/16/2013
• Event Location: Hospital
• Date Manufacturer Received: 12/27/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention