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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 36KHZ STRAIGHT HANDPIECE; ULTRASONIC SURGICAL PRODUCTS
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INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 36KHZ STRAIGHT HANDPIECE; ULTRASONIC SURGICAL PRODUCTS Back to Search Results
Catalog Number C2602
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 06/15/2020
Event Type  malfunction  
Manufacturer Narrative
The device was not yet returned to the manufacturer for analysis.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 c2602 cusa excel 36khz straight handpiece had a vibration error when powered on with cusa excel 9 console.The malfunction was discovered during inspection on (b)(6) 2020.There was no patient involvement or delay in surgery.
 
Manufacturer Narrative
Device identifier: (b)(4).Product identifier: (b)(6).The device was returned for evaluation.The device history record (dhr) was reviewed and no anomalies that could be associated with the complaint incident was observed.The reported complaint was confirmed.Transducer delamination was the root cause of the complaint.
 
Event Description
N/a.
 
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Brand Name
CUSA EXCEL 36KHZ STRAIGHT HANDPIECE
Type of Device
ULTRASONIC SURGICAL PRODUCTS
Manufacturer (Section D)
INTEGRA LIFESCIENCES(IRELAND)
ida business&technology park
ida business&technology park
sragh, tullamore, co.offaly
EI 
MDR Report Key10240807
MDR Text Key198544644
Report Number3006697299-2020-00079
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
PMA/PMN Number
K141668
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberC2602
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2020
Date Manufacturer Received09/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CUSAEXCEL9
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