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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDISAFE UK LTD. INNOWAVE PCF SONIC IRRIGATOR

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MEDISAFE UK LTD. INNOWAVE PCF SONIC IRRIGATOR Back to Search Results
Device Problem Device Fell (4014)
Patient Problem Pain (1994)
Event Date 10/16/2023
Event Type  malfunction  
Event Description
The user facility reported that the lid of their innowave pcf sonic irrigator closed on an employee's arm resulting in an injury.Medical treatment was sought and administered.
 
Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found that no loctite was present on the lid cylinders.As there was no loctite on the lid cylinders, the lid did not operate properly resulting in the reported event.The technician applied loctite to the lid cylinders, tested the unit, confirmed it to be operating according to specification, and returned it to service.On june 16, 2023, a different steris service technician performed preventive maintenance activities on the innowave pcf sonic irrigator.During the preventive maintenance activities, the technician failed to apply loctite to the lid cylinders as directed in the preventive maintenance instructions.The technician was re-trained on the proper maintenance activities for the innowave pcf sonic irrigator, specifically applying loctite to the lid cylinders.No additional issues have been reported.
 
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Brand Name
INNOWAVE PCF SONIC IRRIGATOR
Type of Device
SONIC IRRIGATOR
Manufacturer (Section D)
MEDISAFE UK LTD.
unit 7 & 8, dunmow road
bishops stortford
hertfordshire, CM23 5GZ
UK  CM23 5GZ
Manufacturer (Section G)
MEDISAFE UK LTD.
unit 7 & 8, dunmow road
bishops stortford
hertfordshire, CM23 5GZ
UK   CM23 5GZ
Manufacturer Contact
daniel davy
5960 heisley road
mentor
4403927453
MDR Report Key18093149
MDR Text Key328654193
Report Number9617134-2023-00004
Device Sequence Number1
Product Code MEC
UDI-Device Identifier00724995152710
UDI-Public00724995152710
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/16/2023
Initial Date FDA Received11/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/14/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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