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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2020
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that amplitude error occured during testing of the device for a hepatectomy procedure on (b)(6) 2020.The tip was changed but the issue did not improve.Another device was used to complete the procedure.There was no surgical delay and no impact to patient.
 
Manufacturer Narrative
Unique device identifier: (b)(4).The cusa handpiece was not returned for evaluation; therefore, an evaluation of the device could not be performed.Serial number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
 
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 Key10796708
MDR Text Key228258796
Report Number3006697299-2020-00119
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
PMA/PMN Number
K141674
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
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? No
Date Manufacturer Received11/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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