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Adverse Event Report

BAUSCH & LOMB SURGICAL MILLENNIUM VERTICAL SCISSOR TIP ACCESSORY TO THE MILLENNIUM UNIT   back to search results
Catalog Number CX7110
Device Problem Failure, intermittent
Event Date 09/17/1998
Event Type  Malfunction  
Event Description

During an ophthalmic procedure, this scissor tip functioned intermittently. Another scissor tip was used to complete the procedure.

 
Manufacturer Narrative

Section a through f were completed by the mfr. There was not problem found with the tip. The problem may have been in the handpiece that holds the tip. The handpiece was not returned for eval.

 
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Brand NameMILLENNIUM VERTICAL SCISSOR TIP
Type of DeviceACCESSORY TO THE MILLENNIUM UNIT
Baseline Brand NameMILLENNIUM VERTICAL SCISSOR TIP
Baseline Generic NameACCESSORY TO MILLENNIUM
Baseline Catalogue NumberCX7110
Baseline Device FamilyMILLENNIUM SCISSOR TIP
Baseline Device 510(K) NumberK961310
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed02/28/1997
Manufacturer (Section F)
BAUSCH & LOMB SURGICAL
3365 tree court indl. blvd.
st. louis MO 63122
Manufacturer (Section D)
BAUSCH & LOMB SURGICAL
3365 tree court indl. blvd.
st. louis MO 63122
Manufacturer (Section G)
BAUSCH & LOMB, INC.
499 sovereign ct.
manchester MO 63011
Manufacturer Contact
janet lacavich
3365 tree ct industrial blvd
st. louis , MO 63122
(314) 225 -5051
Device Event Key186675
MDR Report Key192101
Event Key180593
Report Number1932180-1998-00066
Device Sequence Number1
Product CodeHQE
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/17/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCX7110
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/17/1998
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer09/17/1998
Date Manufacturer Received09/17/1998
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on December 31, 2008

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