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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ASSY, CABLE ULTRALITE 2 BIFURC; N/A
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INTEGRA YORK, PA INC. ASSY, CABLE ULTRALITE 2 BIFURC; N/A Back to Search Results
Catalog Number 0029009
Device Problem Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A customer reported that the 0029009 assy, cable ultralite gets very hot when used for a period of time.Additional information received on 28aug2019 indicates that there was no patient contact.The event was noticed before the surgeon received the headlight.A slight delay was reported as they were trying to locate another cable.No medical intervention reported.Problem product discovered while getting the room ready.No other information provided.
 
Event Description
N/a.
 
Manufacturer Narrative
Device identifier: (b)(4).The device was not returned for evaluation.A failure analysis and determination of root cause is not possible due to the lack of information received to perform a complete investigation.Product has not been returned.The reported complaint is unconfirmed.
 
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Brand Name
ASSY, CABLE ULTRALITE 2 BIFURC
Type of Device
N/A
Manufacturer (Section D)
INTEGRA YORK, PA INC.
589 davies drive
589 davies drive
york PA 17402
MDR Report Key9070570
MDR Text Key201663146
Report Number2523190-2019-00111
Device Sequence Number1
Product Code FST
Combination Product (y/n)N
PMA/PMN Number
K864380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 08/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0029009
Was Device Available for Evaluation? No
Date Manufacturer Received09/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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