MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. ENDOSONIC CLEANER 220-240V

Model Number 7500620

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Unintended Electrical Shock (4018)

Patient Problems Shock (2072); No Information (3190)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

Olympus keymed have requested the product to be returned for further investigation.Based on the information provided this complaint has been reported in the abundance of caution, further information has been requested regarding this event and a follow-up report will be provided.

Event Description

The customer reported that they got "micro shocks".

Manufacturer Narrative

Olympus keymed investigation advises it is alleged the event is user error and inappropriate operating environment.Service / maintenance records were requested but not provided which indicated lack of maintenance during the products life span.No report of injury to patient or user.This will be the final report submitted and the pae closed.However, if any new information is presented we will re-open the case and investigate further.

• Brand Name: ENDOSONIC CLEANER 220-240V
• Type of Device: ENDOSONIC CLEANER
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend-on-sea, essex
• MDR Report Key: 7661899
• MDR Text Key: 113631499
• Report Number: 9611174-2018-00011
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• PMA/PMN Number: CLASS 1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7500620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1