MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP SINGLE USE COMBINATION CLEANING BRUSH

Model Number BW-412T

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2015

Event Type  malfunction  

Event Description

During an ercp procedure, a stent was removed from the patient and had gotten stuck in the channel of the scope.When the channel was cleaned using the subject device afterward, the user didn't notice the stent that had gotten stuck in the channel.This scope was used for another procedure after machine cleaning, and the user noticed the stent that had gotten stuck in a channel when a guidewire was inserted.This scope was withdrawn immediately and there was not patient injury reported.

Manufacturer Narrative

The exact cause of the phenomenon could not be conclusively determined since the subject device was not returned to olympus medical systems corp (omsc).This report will be supplemented if any important, additional information is obtained, or the subject device is returned and any significant evaluation result is obtained.

• Brand Name: SINGLE USE COMBINATION CLEANING BRUSH
• Type of Device: COMBINATION CLEANING BRUSH
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 5807; JA 192-5807
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-5-807 ; JA 192-5807 ; 26425177
• MDR Report Key: 4507143
• MDR Text Key: 19351831
• Report Number: 8010047-2015-00063
• Device Sequence Number: 1
• Product Code: MNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BW-412T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1