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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET II EXACT 45DEG X 14MM; LAVAGE, JET

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SMITH & NEPHEW MEDICAL LTD. VERSAJET II EXACT 45DEG X 14MM; LAVAGE, JET Back to Search Results
Catalog Number 66800041
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2020
Event Type  malfunction  
Event Description
It was reported that during surgery the handpiece cable was detached upon using.No backup device was available.Only 25% of the surgery was completed and since there was no backup device available, the surgery was rescheduled.No harm to patient reported.
 
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Brand Name
VERSAJET II EXACT 45DEG X 14MM
Type of Device
LAVAGE, JET
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK  HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK   HU3 2BN
Manufacturer Contact
sarah freestone
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
4407940038
MDR Report Key9940406
MDR Text Key187758015
Report Number8043484-2020-00274
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K110958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66800041
Device Lot Number50822790
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/19/2020
Initial Date FDA Received04/08/2020
Supplement Dates Manufacturer Received12/16/2020
Supplement Dates FDA Received12/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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