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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. TC-C3 TROLLEY US SET 3; TC SERIES OF ENDOSCOPY WORKSTATIONS
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KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. TC-C3 TROLLEY US SET 3; TC SERIES OF ENDOSCOPY WORKSTATIONS Back to Search Results
Model Number K10030136
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus and inspected.During the inspection, a housing slit/crack was found on the rear left caster.This event is under investigation.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
The tc-c3 trolley set 3 was returned to olympus as part of asset return.During manufacturer inspection a slit was found on the housing at the left rear caster.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer's investigation.Based on communication with the supplier the occurrence of this type of failure mode is very low and likely caused by a heavy impact to the castor, causing the housing to split.The castor itself was dated 2018.Olympus will continue to monitor for similar events.
 
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Brand Name
TC-C3 TROLLEY US SET 3
Type of Device
TC SERIES OF ENDOSCOPY WORKSTATIONS
Manufacturer (Section D)
KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
keymed house, stock road
southend-on-sea, essex SS2 5 QH
UK  SS2 5QH
MDR Report Key11408033
MDR Text Key242904994
Report Number9611174-2021-00008
Device Sequence Number1
Product Code FEM
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberK10030136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2021
Was the Report Sent to FDA? No
Date Manufacturer Received04/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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