MAUDE Adverse Event Report: KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. OLYMPUS; WM-260 MOBILE WORKSTATION

Model Number WM-260

Device Problems Device Emits Odor (1425); Smoking (1585); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The wm-260 mobile workstation is intended for use in medical facilities under the direction of a trained physician, and had been designed to be used with the olympus lucera range if equipment as part of an olympus gi endoscopy system.During the preparation for use check undertaken prior to the start of the procedure (therapeutic procedure - endoscopic ultrasound-guided transmural cyst drainage), the operator notice a burning smell from around the device which is the subject of this report and also a slight spark and smoke were generated from the rear panel of the wm-260.The start of the procedure was delayed as the facility changed to another system.There was no report of patient injury and therefore this report is submitted in an abundance of caution.

• Brand Name: OLYMPUS
• Type of Device: WM-260 MOBILE WORKSTATION
• Manufacturer (Section D): KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.; southend on sea, essex ; UK
• Manufacturer Contact: alison prior, ra mgr ; journeyman's way, temple farm; industrial estate; southend on sea, essex SS2 5-TF ; UK SS2 5TF ; 17026163
• MDR Report Key: 3912079
• MDR Text Key: 20856128
• Report Number: 9611174-2014-00003
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WM-260
• Device Catalogue Number: K7503878
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: (B)(4) (IMAGE FILING); OEV261H; (B)(4) DVD RECORDER; UP-897MD; CV-260H; EU-ME1
• Patient Age: 77 YR