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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. ENDOSONIC CLEANER 100V (OT)
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KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. ENDOSONIC CLEANER 100V (OT) Back to Search Results
Model Number 7500617
Device Problems Loss of or Failure to Bond (1068); Disconnection (1171); Smoking (1585); Solder Joint Fracture (2324)
Patient Problem No Information (3190)
Event Date 09/03/2018
Event Type  malfunction  
Manufacturer Narrative
No report of injury to patient or user.Olympus keymed have requested that the product is returned for further investigation and for the interim, provide photos of the fault.Reported in an abundance of caution.
 
Event Description
After being turned on, smoke occurred from rear side.
 
Manufacturer Narrative
Keymed investigation has been completed.Product is of considerable age and the investigation outcome was determined as transducer/bonding failure/solder failure.Inadequate maintenance also contributed to the fault.There was no report of injury of to patient or user.This will be the final follow up report, however, if any new information is provided the case will be re-opened and investigated further.
 
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Brand Name
ENDOSONIC CLEANER 100V (OT)
Type of Device
ENDOSONIC CLEANER
Manufacturer (Section D)
KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
keymed house, stock road
southend-on-sea, essex
MDR Report Key7880165
MDR Text Key120708296
Report Number9611174-2018-00015
Device Sequence Number1
Product Code FLG
Combination Product (y/n)N
PMA/PMN Number
CLASS 1
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 10/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number7500617
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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